NA 219.99Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10886982156297), received between Dec 6, 2017 and Sep 15, 2023 — classified as 16 injuries.

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

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2008, THE PATIENT HAD CAR/CAR COLLISION AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT UNDERWENT SEVERAL SURGERIES FOR ORTHOPEDIC INJURIES INCLUDING AN OPEN REDUCTION INTERNAL FIXATION FOR A FRACTURE-DISLOCATION OF HIS FEMORAL HEAD AND NECK AND A SACROILIAC SCREW FIXATION AND ANTERIOR PUBIC PLATE FOR MALGAIGNE FRACTURE. ON (B)(6) 2008 THE PATIENT UNDERWENT ORIF LEFT FEMORAL HEAD, ORIF LEFT FEMORAL NECK, ORIF LEFT ANTERIOR COLUMN ACETABULUM, ORIF PUBIC SYMPHYSIS (SYNTHES PELVIC PLATE ACROSS HIS PUBIS EXTENDING TO THE LEFT HIP) AND PERCUTANEOUS ILIOSACRAL SCREW FIXATION DUE TO LEFT ACETABULAR FRACTURE AND LEFT FEMORAL HEAD FRACTURE. ON (B)(6) 2010 THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY WITH DEPUY COMPONENTS DUE TO HIP PAIN, METALLOSIS, TRAUMATIC ARTHRITIS LEFT HIP WITH FEMORAL HEAD AVASCULAR NECROSIS AND NONUNION FEMORAL HEAD FRACTURE, MALGAIGNE FRACTURE AND INTRAARTICULAR HARDWARE BROKE WITH SCREWS. THIS REPORT INVOLVES ONE (1) WASHER 13.0MM. THIS IS REPORT 2 OF 10 FOR (B)(4). THIS PRODUCT COMPLAINT IS RELATED TO (B)(4). (B)(4) CAPTURES ADDITIONAL IMPACTED PRODUCTS RELATED TO THIS EVENT.

  Patient problems: Foreign Body Reaction; Necrosis; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 17754985 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 WASHER 13.0MM & 2*UNK - SCREWS: 6.5 MM CANCELLOUS REVISED DUE TO NON-UNION. DEVICE WAS EXPLANTED DUE TO NON-UNION. DATE OF REVISION SURGERY IS (B)(6) 2023.REASON FOR REVISION SURGERY IS NON-UNION. THERE WAS PATIENT CONSEQUENCE. NON-UNION PLUS REVISION SURGERY. THIS REPORT IS FOR ONE (1) WASHER 13.0MM THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16584051 ↗
• InjuryJan 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGERY ON (B)(6) 2021 TO REMOVE A 6.5MM CANCELLOUS SCREW AND WASHER BECAUSE OF PAIN FROM A TALUS/CALCANEUS. THE HARDWARE WAS SUCCESSFULLY REMOVED. THIS REPORT IS FOR (1) WASHER 13.0MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 13239843 ↗
• InjuryNov 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A HARDWARE REMOVAL FROM THEIR LEFT PELVIS AND LEFT ANKLE DUE TO PAIN. TWO (2) WASHERS WERE RETAINED IN THE PATIENT¿S PELVIS. THE SURGEON REMOVED 7.3MM CANNULATED SCREWS FROM THE PELVIS FROM THE LEFT ANKLE FOUR (4) PLATES AND 28 SCREWS WERE REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT IS LINKED TO (B)(4). THIS REPORT IS FOR ONE (1) WASHER 13.0MM. THIS IS REPORT 5 OF 20 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12728759 ↗
• InjuryApr 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REMOVAL OF THREE (3) CANNULATED SCREWS AND ONE (1) WASHER AND WAS REVISED TO HEMIARTHROPLASTY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) WASHER 13.0MM THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11704138 ↗
• InjuryApr 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT A REMOVAL HARDWARE PROCEDURE FROM A PROXIMAL TIBIA DUE TO PAIN. REMOVAL OF TWO (2) 6.5/7.3 CANNULATED SCREWS AND TWO (2) 13MM WASHERS FROM A PROXIMAL TIBIA THAT HAD HEALED. THE PATIENT REQUESTED TO HAVE THE HARDWARE REMOVED BECAUSE OF PAIN. THE HARDWARE WAS REMOVED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) WASHER 13.0MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 11701460 ↗
• InjuryApr 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, PATIENT UNDERWENT A REMOVAL HARDWARE PROCEDURE FROM A PROXIMAL TIBIA DUE TO PAIN. REMOVAL OF TWO (2) 6.5/7.3 CANNULATED SCREWS AND TWO (2) 13MM WASHERS FROM A PROXIMAL TIBIA THAT HAD HEALED. THE PATIENT REQUESTED TO HAVE THE HARDWARE REMOVED BECAUSE OF PAIN. THE HARDWARE WAS REMOVED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) WASHER 13.0MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 11701344 ↗
• InjuryFeb 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HARDWARE REMOVAL ON (B)(6) 2021. ONE (1) 6.5MM CANNULATED SCREW 32MM THREAD 80MM AND ONE (1) WASHER 13.0MM WERE EXPLANTED FROM THE PELVIS DUE TO PAIN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - PLATE: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) WASHER 13.0MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 11330329 ↗
• InjuryNov 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT RETURNED TO SURGERY FOR HARDWARE REMOVAL AND TOTAL HIP REPLACEMENT DUE TO A FRACTURE. THE PATIENT SUSTAINED A SUBTROCHANTERIC FRACTURE TO CANNULATED HIP SCREWS. UNCLEAR IF FRACTURE WAS PRESENT ALREADY. THE PATIENT AND PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) WASHER 13.0MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 10773382 ↗
• InjuryJul 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT REMOVAL OF PELVIC HARDWARE DUE TO PAIN. TWO (2) FULLY THREADED CANNULATED SCREWS AND TWO (2) 13.0MM WASHERS WERE REPORTED TO HAVE AN UNKNOWN ISSUE. SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF UNSPECIFIED AMOUNT OF TIME. PATIENT OUTCOME WAS NOT KNOWN. THIS REPORT IS FOR ONE (1) 13.0MM WASHER. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7658762 ↗
• InjuryJun 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7644097 ↗
• InjuryMar 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2016 AFTER A PATIENT SUFFERED A GUNSHOT WOUND WHERE ONE (1) 2.4MM LOCKING COMPRESSION PLATE (LCP), FOUR (4) 7.3MM CANNULATED SCREWS, FOUR (4) WASHERS, TWO (2) 2.4MM LOCKING SCREWS, AND ONE (1) 2.4MM CORTEX SCREW WAS IMPLANTED. POST-OPERATIVELY, PATIENT RETURNED TO SURGERY DUE TO A NONUNION. REVISION SURGERY WAS PERFORMED ON (B)(6) 2018, WHERE ALL PREVIOUS IMPLANTS WERE REMOVED AND PATIENT RECEIVED A TOTAL HIP REPLACEMENT. THERE WAS NO SURGICAL DELAY AND SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT STATUS WAS REPORTED AS OK. THIS COMPLAINT INVOLVES 12 PARTS (FOUR UNK-7.3MM CANNULATED SCREWS, FOUR WASHERS, ONE PLATE, TWO UNK-2.4M LOCKING SCREWS AND ONE UNK-2.4MM CORTEX SCREW) THIS REPORT IS FOR (1) WASHER 13.0MM. THIS REPORT IS 8 OF 8 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7329545 ↗
• InjuryMar 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2016 AFTER A PATIENT SUFFERED A GUNSHOT WOUND WHERE ONE (1) 2.4MM LOCKING COMPRESSION PLATE (LCP), FOUR (4) 7.3MM CANNULATED SCREWS, FOUR (4) WASHERS, TWO (2) 2.4MM LOCKING SCREWS, AND ONE (1) 2.4MM CORTEX SCREW WAS IMPLANTED. POST-OPERATIVELY, PATIENT RETURNED TO SURGERY DUE TO A NONUNION. REVISION SURGERY WAS PERFORMED ON (B)(6) 2018, WHERE ALL PREVIOUS IMPLANTS WERE REMOVED AND PATIENT RECEIVED A TOTAL HIP REPLACEMENT. THERE WAS NO SURGICAL DELAY AND SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT STATUS WAS REPORTED AS OK. THIS COMPLAINT INVOLVES 12 PARTS (FOUR UNK-7.3MM CANNULATED SCREWS, FOUR WASHERS, ONE PLATE, TWO UNK-2.4M LOCKING SCREWS AND ONE UNK-2.4MM CORTEX SCREW). THIS REPORT IS FOR (1) WASHER 13.0MM. THIS REPORT IS 7 OF 8 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7329544 ↗
• InjuryMar 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2016 AFTER A PATIENT SUFFERED A GUNSHOT WOUND WHERE ONE (1) 2.4 MM LOCKING COMPRESSION PLATE (LCP), FOUR (4) 7.3 MM CANNULATED SCREWS, FOUR (4) WASHERS, TWO (2) 2.4 MM LOCKING SCREWS, AND ONE (1) 2.4 MM CORTEX SCREW WAS IMPLANTED. POST-OPERATIVELY, PATIENT RETURNED TO SURGERY DUE TO A NONUNION. REVISION SURGERY WAS PERFORMED ON (B)(6) 2018, WHERE ALL PREVIOUS IMPLANTS WERE REMOVED AND PATIENT RECEIVED A TOTAL HIP REPLACEMENT. THERE WAS NO SURGICAL DELAY AND SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT STATUS WAS REPORTED AS OK. THIS COMPLAINT INVOLVES 12 PARTS (FOUR UNK-7.3 MM CANNULATED SCREWS, FOUR WASHERS, ONE PLATE, TWO UNK-2.4 M LOCKING SCREWS AND ONE UNK-2.4 MM CORTEX SCREW) THIS REPORT IS FOR (1) WASHER 13.0 MM . THIS REPORT IS 6 OF 8 FOR (B)(4).

  Patient problems: Not Applicable

  MAUDE report 7329543 ↗
• InjuryMar 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2016 AFTER A PATIENT SUFFERED A GUNSHOT WOUND WHERE ONE (1) 2.4MM LOCKING COMPRESSION PLATE (LCP), FOUR (4) 7.3MM CANNULATED SCREWS, FOUR (4) WASHERS, TWO (2) 2.4MM LOCKING SCREWS, AND ONE (1) 2.4MM CORTEX SCREW WAS IMPLANTED. POST-OPERATIVELY, PATIENT RETURNED TO SURGERY DUE TO A NONUNION. REVISION SURGERY WAS PERFORMED ON (B)(6) 2018, WHERE ALL PREVIOUS IMPLANTS WERE REMOVED AND PATIENT RECEIVED A TOTAL HIP REPLACEMENT. THERE WAS NO SURGICAL DELAY AND SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT STATUS WAS REPORTED AS OK. THIS COMPLAINT INVOLVES 12 PARTS (FOUR UNK-7.3MM CANNULATED SCREWS, FOUR WASHERS, ONE PLATE, TWO UNK-2.4M LOCKING SCREWS AND ONE UNK-2.4MM CORTEX SCREW). THIS REPORT IS FOR (1) WASHER 13.0MM . THIS REPORT IS 5 OF 8 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7329541 ↗
• InjuryDec 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH THREE (3) 7.3MM CANNULATED SCREWS AND THREE (3) 13.0MM WASHERS ON (B)(6) 2017 TO TREAT A SUB CAPITAL HIP FRACTURE. PATIENT PRESENTED TO EMERGENCY ROOM ON (B)(6) 2017 COMPLAINING OF PAIN. X-RAYS SHOWED FRACTURE HEALED AND ONE OF THE SCREWS HAD CUT OUT PROXIMALLY. PATIENT UNDERWENT HARDWARE REMOVAL ON (B)(6) 2017. THERE WERE NO REPORTED ISSUES WITH THE WASHERS OR OTHER TWO (2) SCREWS. THE SURGEON EASILY REMOVED THE FIRST SCREW AND EXPERIENCED DIFFICULTY REMOVING THE FIRST WASHER. THE INCISION WAS SLIGHTLY EXTENDED IN ORDER TO REMOVE THE WASHER. ONCE THE INCISION WAS MADE, THE SURGEON EASILY REMOVED THE FIRST WASHER AND REMOVED THE TWO SCREWS AND TWO WASHERS WITHOUT ISSUE. THERE WAS AN APPROXIMATE FIVE MINUTE SURGICAL DELAY. PATIENT WAS NOT REVISED TO ANY ADDITIONAL HARDWARE, AS THE FRACTURED HEALED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS REPORTED TO BE STABLE. PC-000057062 ADDRESSES THE SCREW CUT OUT AND HARDWARE REMOVAL. THIS REPORT ADDRESSES THE DIFFICULTY WITH REMOVAL OF THE WASHER AND INCISION EXTENSION. CONCOMITANT DEVICES REPORTED: 7.3MM CANNULATED SCREW, 16MM THREAD, STAINLESS STEEL (PARTIAL PART 208.8XX,

  Patient problems: No Code Available

  MAUDE report 7086731 ↗