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GAMMA 3325-0380SRecalls & reported problems

Stryker GmbH · Long Nail Kit R2.0, Ti, LEFT · Class 2 · Implant

Adverse event reports
21
Deaths reported
0
Injuries reported
21
Recalls naming it
0

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 07613153313533), received between Oct 18, 2016 and Oct 21, 2021 — classified as 21 injuries.

The most frequently reported specific device problem is “Fracture” (8 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Fracture8
  • Appropriate Device Problem Term/Code Not Available6
  • Adverse Event Without Identified Device or Use Problem4
  • Insufficient Device Problem Information2
  • Break1

Patient problems

  • Failure of Implant6
  • Injury5
  • No Code Available5
  • Death3
  • Nonunion/Delayed-union Bone Fracture2
  • Pain2
  • Arthritis1
  • Bone Fracture(s)1

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 21, 2021Fracture; Fracture

    IT WAS REPORTED A PATIENT WITH NORMAL WEIGHT SHOWED FRACTURE OF THE GAMMA NAIL FOUR WEEKS AFTER IMPLANTATION. IN THE FURTHER COURSE, THE LOCKING SCREW ALSO BROKE, EVEN IF THE SCREW IN THIS CASE IS TO BE CONSIDERED TOO SHORT. THE PATIENT REQUIRED A REVISION SURGERY.

    Patient problems: Failure of Implant

    MAUDE report 12676146 ↗
  • InjuryOct 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE SURGEON REPORTED THAT THE PATIENT WHO HAD BEEN IMPLANTED WITH A GAMMA LONG NAIL NEEDS REVISION SURGERY. ADDITIONALLY REPORTED: PATIENT PRESENTED IN A&E ON (B)(6) 2020. PATIENT TRIPPED AND FELL, FRESH FRACTURE TO THE FEMUR WAS NOTED, NAIL INTACT. PATIENT HAS FIBROUS DYSPLASIA.

    Patient problems: Limb Fracture

    MAUDE report 10757461 ↗
  • InjuryMar 17, 2020Fracture; Fracture

    THE CUSTOMER REPORTED THAT THE GAMMA NAIL BROKE. X-RAY IMAGE ALSO SHOWED BROKEN LOCKING SCREW. REVISION SURGERY OCCURRED AS A RESULT.

    Patient problems: Failure of Implant; Injury

    MAUDE report 9845752 ↗
  • InjuryMar 17, 2020Fracture; Fracture

    IT WAS REPORTED THAT THE PATIENT'S LEFT FEMUR WAS REVISED DUE TO NON-UNION AND A BROKEN GAMMA NAIL AT THE JUNCTION WITH THE LAG SCREW. POSSIBLE CAUSE OR CONTRIBUTOR FOR IMPLANT BREAKAGE WAS NOT REPORTED TO THE REP. REP CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: Failure of Implant; Injury; Nonunion/Delayed-union Bone Fracture

    MAUDE report 9845303 ↗
  • InjuryFeb 18, 2020Fracture; Fracture

    THE CUSTOMER REPORTS A BREAKAGE OF THE NAIL. A REVISION SURGERY WAS PERFORMED.

    Patient problems: Failure of Implant; Injury

    MAUDE report 9721514 ↗
  • InjuryFeb 17, 2020Fracture; Fracture

    ON (B)(6) 2020: A SALES ORDER WAS PLACED FOR AN ELONGATED G3 NAIL AS REPLACEMENT FOR A BROKEN ONE IN A PATIENT. THE PATIENT SEEMS TO HAVE DEVELOPED A BONE TUMOR IN THE PROXIMAL LEFT FEMUR. ON 2016: AN ELONGATED GAMMA3 NAIL LEFT WAS PLACED IN THE LEFT FEMUR BACK IN 2016. ON (B)(6) 2016: A SECONDARY TUMOR WAS FOUND IN THE LEFT PROXIMAL FEMUR. THE PATIENT HAD ALREADY PROSTATE CANCER. ON (B)(6) 2016: A 3325-0380S GAMMA3 LONG NAIL KIT R2.0, TI LEFT, Ø11X380 MM X 125° WAS PLACED IN THE LEFT FEMUR. ON (B)(6) 2019: AT A CONTROL THE NAIL IS STILL INTACT, BUT THE TUMOR IS EXPANDING. ON (B)(6) 2020: PATIENT EXPERIENCED PAIN IN HIS LEFT PROXIMAL FEMUR. ON (B)(6) 2020: PATIENT EXPERIENCED SEVERE PAIN IN HIS LEFT PROXIMAL FEMUR. ON (B)(6) 2020: AN X-RAY SHOWS THAT THE NAIL IS BROKEN AT THE LEVEL OF THE LAG SCREW. ON (B)(6) 2020: A SALES ORDER WAS PLACED FOR AN THICKER ELONGATED G3 NAIL AS REPLACEMENT FOR A BROKEN ONE IN A PATIENT. ON (B)(6) 2020: A 3525-3380S GAMMA3 LONG NAIL KIT R1.5, TI LEFT, Ø13X380 MM X 125° WAS PLACED.

    Patient problems: Failure of Implant; Injury; Pain

    MAUDE report 9718033 ↗
  • InjuryJan 6, 2020Fracture; Fracture

    AS REPORTED BY ATTORNEY: PATIENT CAME IN WITH PAIN. AN X-RAY OF THE HIP AND THIGH ON THE LEFT IN TWO PLANES REVEALED THE FOLLOWING FINDINGS: URGENT SUSPICION OF REFRACTURE OF THE PREVIOUSLY DESCRIBED SUBTROCHANTERIC FEMUR FRACTURE. THE FRACTURE GAP IS CLEARLY VISIBLE. BUCKLING OF THE GAMMA NAIL AT THE LEVEL OF THE FEMORAL NECK SCREW AS AN INDICATION OF MATERIAL BREAKAGE. OSTEOPENIA. REVISION ON (B)(6) 2016. GAMMA NAIL WAS REMOVED AND A NEW ONE WAS IMPLANTED. STRYKER ALSO BECAME AWARE THAT PATIENT HAS DIED ON (B)(6) 2017. THE CAUSE OF THE DEATH IS UNKNOWN THEREFORE THE EVENT WILL BE REPORTED SEPARATELY.

    Patient problems: Failure of Implant; Injury; Pain

    MAUDE report 9555934 ↗
  • InjuryOct 1, 2018Break

    GAMMA3 NAIL WOULD BE REMOVED AND REPLACED FOR A TOTAL HIP PROSTHESIS ON (B)(6) 2018 BY DR. (B)(6). REASON TOTAL HIP PROSTHESIS UNKNOWN. GAMMA3 NAIL PLACED ON (B)(6) 2013 BY DR. (B)(6). NOT KNOWN HOW THAT OPERATION WENT. ONE DISTAL SCREW IS PLACED IN THE STATIC HOLE. ON X-RAY PHOTO IT HAS BEEN FOUND THAT THE DISTAL SCREW IS BROKEN. PROXIMAL PART SEEMS TO BE INTACT AT THAT MOMENT. THE COLLUM SCREW IS REMOVED AND THEN THE EXTRACTOR IS ATTACHED TO THE NAIL. DISTAL SCREW THE LATERAL PART IS REMOVED. WHEN REMOVING THE GAMMA3 PEN WITH EXTRACTOR, THE UPPER PART BREAKS OFF. REMAINDER OF THE PEN IS REMOVED WITH HOOK WIRE. THE MEDIAL PART OF THE DISTAL SCREW REMAINS IN THE PATIENT AND APPEARS TO CAUSE DAMAGE TO THE CORTEX. IT IS DECIDED TO FIRST MAKE A CT AND THEN DECIDE WHICH PROSTHESIS CAN BEST BE PLACED. NEW TOTAL HIP SURGERY WAS POSTPONED, PATIENT STILL HAS A PART OF THE DISTAL SCREW IN BODY. A CT SCAN HAS TO BE PERFORMED.

    Patient problems: Foreign Body In Patient

    MAUDE report 7923899 ↗
  • InjuryAug 14, 2018Adverse Event Without Identified Device or Use Problem

    THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE NORWEGIAN HIP FRACTURE REGISTER. THE TITLE OF THIS REPORT IS ¿GAMMA 3 IN THE NORWEGIAN HIP FRACTURE REGISTER¿ WHICH IS ASSOCIATED WITH THE GAMMA3 LOCKING NAIL SYSTEM, WITHIN THAT REPORT, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN 1-JAN-2005 AND 31-DEC-2016. A REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED PREVIOUSLY TO STRYKER, THEREFORE 290 COMPLAINTS WERE INITIATED FOR THE REVISION SURGERIES RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES REVISION SURGERY DUE TO UNKNOWN REASON. THE 157 OUT OF 290 CASES. IT WAS ALSO INDICATED THAT PATIENT DIED WITHIN 60 DAYS OF REVISION SURGERY HOWEVER THE CAUSE AND DATE OF DEATH WILL NOT BE DISCLOSED.

    Patient problems: Death

    MAUDE report 7780824 ↗
  • InjuryAug 14, 2018Fracture

    THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE NORWEGIAN HIP FRACTURE REGISTER. THE TITLE OF THIS REPORT IS ¿GAMMA 3 IN THE NORWEGIAN HIP FRACTURE REGISTER¿ WHICH IS ASSOCIATED WITH THE GAMMA3 LOCKING NAIL SYSTEM, WITHIN THAT REPORT, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN 1-JAN-2005 AND 31-DEC-2016. A REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED PREVIOUSLY TO STRYKER, THEREFORE 290 COMPLAINTS WERE INITIATED FOR THE REVISION SURGERIES RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES REVISION SURGERY DUE TO OSTEOSYNTHESIS FAILURE AND NEW FRACTURE AROUND IMPLANT. RE-OSTESYNTHESIS WAS PERFORMED. THE 260 OUT OF 290 CASES.

    Patient problems: Hip Fracture

    MAUDE report 7780663 ↗
  • InjuryAug 14, 2018Adverse Event Without Identified Device or Use Problem

    THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE (B)(6) HIP FRACTURE REGISTER. THE TITLE OF THIS REPORT IS ¿GAMMA 3 IN THE (B)(6) HIP FRACTURE REGISTER¿ WHICH IS ASSOCIATED WITH THE GAMMA3 LOCKING NAIL SYSTEM, WITHIN THAT REPORT, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN 1-JAN-2005 AND 31-DEC-2016. A REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED PREVIOUSLY TO STRYKER, THEREFORE (B)(4) COMPLAINTS WERE INITIATED FOR THE REVISION SURGERIES RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES REVISION SURGERY DUE TO SEQUELE AFTER HIP FRACTURE; 101 OUT OF 290 CASES.

    Patient problems: Bone Fracture(s)

    MAUDE report 7780002 ↗
  • InjuryAug 13, 2018Adverse Event Without Identified Device or Use Problem

    THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE NORWEGIAN HIP FRACTURE REGISTER. THE TITLE OF THIS REPORT IS ¿GAMMA 3 IN THE NORWEGIAN HIP FRACTURE REGISTER¿ WHICH IS ASSOCIATED WITH THE GAMMA 3 LOCKING NAIL SYSTEM, WITHIN THAT REPORT, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN 1-JAN-2005 AND 31-DEC-2016. A REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED PREVIOUSLY TO STRYKER, THEREFORE 290 COMPLAINTS WERE INITIATED FOR THE REVISION SURGERIES RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES REVISION SURGERY DUE TO PRIMARY OSTEOARTHRITIS. THE 38 OUT OF 290 CASES.

    Patient problems: Arthritis

    MAUDE report 7778860 ↗
  • InjuryAug 13, 2018Appropriate Device Problem Term/Code Not Available

    THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE NORWEGIAN HIP FRACTURE REGISTER. THE TITLE OF THIS REPORT IS ¿GAMMA 3 IN THE NORWEGIAN HIP FRACTURE REGISTER¿ WHICH IS ASSOCIATED WITH THE GAMMA 3 LOCKING NAIL SYSTEM, WITHIN THAT REPORT, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN 1-JAN-2005 AND 31-DEC-2016. A REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED PREVIOUSLY TO STRYKER, THEREFORE 290 COMPLAINTS WERE INITIATED FOR THE REVISION SURGERIES RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES REVISION SURGERY DUE TO SEQUELAE AFTER PROXIMAL FRACTURE. CASE 33 OUT OF 290 CASES.

    Patient problems: No Code Available

    MAUDE report 7777870 ↗
  • InjuryAug 10, 2018Appropriate Device Problem Term/Code Not Available

    THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE (B)(4) HIP FRACTURE REGISTER. THE TITLE OF THIS REPORT IS ¿GAMMA 3 IN THE (B)(4) HIP FRACTURE REGISTER¿ WHICH IS ASSOCIATED WITH THE GAMMA3 LOCKING NAIL SYSTEM, WITHIN THAT REPORT, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN 1-JAN-2005 AND 31-DEC-2016. A REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED PREVIOUSLY TO STRYKER, THEREFORE 290 COMPLAINTS WERE INITIATED FOR THE REVISION SURGERIES RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES REVISION SURGERY DUE TO OSTEOSYNTHESIS FAILURE. RE-OSTESYNTHESIS WAS PERFORMED. ONE HUNDRED AND EIGHTY-FIVE OUT OF 290 CASES. IT WAS ALSO INDICATED THAT PATIENT DIED WITHIN 60 DAYS OF REVISION SURGERY HOWEVER THE CAUSE AND DATE OF DEATH WILL NOT BE DISCLOSED.

    Patient problems: Death

    MAUDE report 7773044 ↗
  • InjuryAug 10, 2018Insufficient Device Problem Information

    THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE (B)(4) HIP FRACTURE REGISTER. THE TITLE OF THIS REPORT IS ¿GAMMA 3 IN THE (B)(4) HIP FRACTURE REGISTER¿ WHICH IS ASSOCIATED WITH THE GAMMA3 LOCKING NAIL SYSTEM, WITHIN THAT REPORT, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN 1-JAN-2005 AND 31-DEC-2016. A REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED PREVIOUSLY TO STRYKER, THEREFORE 290 COMPLAINTS WERE INITIATED FOR THE REVISION SURGERIES RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES REVISION SURGERY DUE TO SEQUELE AFTER HIP FRACTURE. ONE HUNDRED AND TWENTY-EIGHT OUT OF 290 CASES.

    Patient problems: No Code Available

    MAUDE report 7773043 ↗
  • InjuryAug 10, 2018Appropriate Device Problem Term/Code Not Available

    THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE NORWEGIAN HIP FRACTURE REGISTER. THE TITLE OF THIS REPORT IS ¿GAMMA 3 IN THE NORWEGIAN HIP FRACTURE REGISTER¿ WHICH IS ASSOCIATED WITH THE GAMMA 3 LOCKING NAIL SYSTEM, WITHIN THAT REPORT, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN 1-JAN-2005 AND 31-DEC-2016. A REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED PREVIOUSLY TO STRYKER, THEREFORE 290 COMPLAINTS WERE INITIATED FOR THE REVISION SURGERIES RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES REVISION SURGERY (DRAINAGE) DUE TO INFECTION. CASE 127 OUT OF 290 CASES. IT WAS ALSO INDICATED THAT PATIENT DIED WITHIN 60 DAYS OF REVISION SURGERY HOWEVER THE CAUSE AND DATE OF DEATH WILL NOT BE DISCLOSED.

    Patient problems: Death

    MAUDE report 7773041 ↗
  • InjuryAug 10, 2018Appropriate Device Problem Term/Code Not Available

    THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE (B)(4) HIP FRACTURE REGISTER. THE TITLE OF THIS REPORT IS ¿GAMMA 3 IN THE (B)(4) HIP FRACTURE REGISTER¿ WHICH IS ASSOCIATED WITH THE GAMMA3 LOCKING NAIL SYSTEM, WITHIN THAT REPORT, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN 1-JAN-2005 AND 31-DEC-2016. A REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED PREVIOUSLY TO STRYKER, THEREFORE 290 COMPLAINTS WERE INITIATED FOR THE REVISION SURGERIES RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES REVISION SURGERY DUE TO OSTEOSYNTHESIS FAILURE. THE PATIENT RECEIVED A HIP BIPOLAR HEMIARTHROPLASTY. TWENTY-FIVE OUT OF 290 CASES.

    Patient problems: No Code Available

    MAUDE report 7772213 ↗
  • InjuryAug 10, 2018Insufficient Device Problem Information

    THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE (B)(4) HIP FRACTURE REGISTER. THE TITLE OF THIS REPORT IS ¿GAMMA 3 IN THE (B)(4) HIP FRACTURE REGISTER¿ WHICH IS ASSOCIATED WITH THE GAMMA3 LOCKING NAIL SYSTEM, WITHIN THAT REPORT, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN 1-JAN-2005 AND 31-DEC-2016. A REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED PREVIOUSLY TO STRYKER, THEREFORE 290 COMPLAINTS WERE INITIATED FOR THE REVISION SURGERIES RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES REVISION SURGERY DUE TO UNKNOWN REASON. FIFTY-FOUR OUT OF 290 CASES.

    Patient problems: No Code Available

    MAUDE report 7772148 ↗
  • InjuryAug 10, 2018Appropriate Device Problem Term/Code Not Available

    THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE NORWEGIAN HIP FRACTURE REGISTER. THE TITLE OF THIS REPORT IS ¿GAMMA 3 IN THE NORWEGIAN HIP FRACTURE REGISTER¿ WHICH IS ASSOCIATED WITH THE GAMMA 3 LOCKING NAIL SYSTEM, WITHIN THAT REPORT, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN 1-JAN-2005 AND 31-DEC-2016. A REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED PREVIOUSLY TO STRYKER, THEREFORE 290 COMPLAINTS WERE INITIATED FOR THE REVISION SURGERIES RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES REVISION SURGERY (REMOVAL OF IMPLANT) DUE TO OSTEOSYNTHESIS FAILURE. CASE 27 OUT OF 290 CASES.

    Patient problems: No Code Available

    MAUDE report 7771600 ↗
  • InjuryAug 10, 2018Appropriate Device Problem Term/Code Not Available

    THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE NORWEGIAN HIP FRACTURE REGISTER. THE TITLE OF THIS REPORT IS ¿GAMMA 3 IN THE NORWEGIAN HIP FRACTURE REGISTER¿ WHICH IS ASSOCIATED WITH THE GAMMA 3 LOCKING NAIL SYSTEM, WITHIN THAT REPORT, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN 1-JAN-2005 AND 31-DEC-2016. A REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED PREVIOUSLY TO STRYKER, THEREFORE 290 COMPLAINTS WERE INITIATED FOR THE REVISION SURGERIES RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES REVISION SURGERY DUE TO MALUNION. RE-OSTEOSYNTHESIS WAS PERFORMED. CASE 19 OUT OF 290 CASES.

    Patient problems: Nonunion/Delayed-union Bone Fracture

    MAUDE report 7771590 ↗
  • InjuryOct 18, 2016Fracture; Fracture

    IT WAS REPORTED THAT GAMMA NAIL BROKE AFTER IMPLANTATION.

    Patient problems: No Information

    MAUDE report 6037881 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.