APEXRecalls & reported problems across all models
Stryker GmbH · 15 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 87
- Deaths reported
- 0
- Injuries reported
- 58
- Recalls
- 0
We found 15 models of APEX by Stryker GmbH in the FDA's device registry (GUDID). Together they are named in 87 adverse event reports in the FDA's MAUDE database, received between Sep 1, 2015 and Sep 25, 2025 — classified as 58 injuries, 29 malfunctions.
The most frequently reported specific device problem is “Break” (22 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported APEX problems
Device problems
- Adverse Event Without Identified Device or Use Problem36
- Break22
- Fracture18
- Patient-Device Incompatibility13
- Detachment Of Device Component5
- Mechanical Jam2
- Detachment of Device or Device Component1
- Device Contaminated During Manufacture or Shipping1
Patient problems
- Unspecified Infection16
- Foreign Body In Patient15
- Irritation12
- Device Embedded In Tissue or Plaque9
- No Known Impact Or Consequence To Patient8
- Nonunion/Delayed-union Bone Fracture7
- Failure of Implant6
- Pain4
APEX models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- APEX 5038-1-080PIN, FIXATION, THREADED48 reports
- APEX 5038-2-110PIN, FIXATION, THREADED11 reports
- APEX 5038-2-110SPIN, FIXATION, THREADED8 reports
- APEX 5018-5-150PIN, FIXATION, THREADED6 reports
- APEX 5017-4-180SPIN, FIXATION, THREADED2 reports
- APEX 5016-5-111PIN, FIXATION, THREADED2 reports
- APEX 5018-5-120PIN, FIXATION, THREADED2 reports
- APEX 5018-5-150SPIN, FIXATION, THREADED1 report
- APEX 5018-6-150SPIN, FIXATION, THREADED1 report
- APEX 5038-2-080SPIN, FIXATION, THREADED1 report
- APEX 5014-3-180SPIN, FIXATION, THREADED1 report
- APEX 5038-2-080PIN, FIXATION, THREADED1 report
- APEX 5018-5-200PIN, FIXATION, THREADED1 report
- APEX 5050-5-250PIN, FIXATION, THREADED1 report
- APEX 5030-5-250PIN, FIXATION, THREADED1 report
Recent APEX adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 25, 2025Break; Fracture; Break; Fracture
AS REPORTED: "DURING A PRECISION NAVIGATION TKA CASE. THE APEX PIN SNAPPED INSIDE THE PATIENTS TIBIA DURING INSERTION AT THE START OF THE CASE. THE BROKEN END COULD NOT BE RETRIEVED AND A NEW PIN WAS OPENED AND USED. SURGICAL DELAY WHILE TRYING TO RETRIEVE THE BROKEN END."
Patient problems: Foreign Body In Patient
MAUDE report 23144772 ↗InjuryNov 22, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE PIN WENT INTO THE LEFT NOSTRIL OF THE NURSE'S FACE AND FRACTURED THE RIGHT ORBITAL FLOOR DURING A CASE AT THE USER FACILITY. ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE USER FACILITY.
Patient problems: Bone Fracture(s)
MAUDE report 20758114 ↗InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PRESENT SWISS TRAUMA FRACTURE REGISTRY (SWTR) IS A PROSPECTIVE, MULTI-CENTER, OBSERVATIONAL STUDY TO COLLECT DATA ON ALL STRYKER TRAUMA AND EXTREMITIES PRODUCTS WITH THE AIM TO ADD TO THE EXISTING CLINICAL EVIDENCE TO SUPPORT THE SAFETY AND PERFORMANCE OF STRYKER IMPLANTS FOR THE APPROVED INDICATIONS FOR USE. THE SWTR CAPTURES DATA EVALUATING THE REAL-WORLD USAGE OF STRYKER IMPLANTS AT TRAUMA CENTERS WITH THE CAPACITY, TRAINING, AND EXPERIENCE TO GATHER CLINICALLY RELEVANT STANDARD OF CARE SAFETY AND PERFORMANCE ENDPOINT DATA. DURING THE REVIEW OF THE REPORT, DELAYED WOUND HEALING WAS NOTED FOR THIS PATIENT DURING THE FOLLOW-UP VISIT.
Patient problems: Impaired Healing
MAUDE report 19956380 ↗MalfunctionMar 25, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED: "DURING INBOUND PROCESSING, IT WAS NOTICED HAIR UNDER THE SHRINK WRAP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18970297 ↗InjuryMar 20, 2024Break; Fracture; Break; Fracture
IT WAS REPORTED BY THE SALES REP THAT ONE OF THE NAVIGATION PIN WAS BROKEN AND LEFT INSIDE PATIENT TIBIA BONE WHEN SURGERY FINISHING AND SURGEON WAS DRILLING THE PIN OUT. SURGEON DECIDED TO LEAVE IT INSIDE THE PATIENT BONE. HOSPITAL RAISED SERIOUS INCIDENCE REPORT BECAUSE IT WAS CONSIDERED AS "SHARP". BASED ON THE INFORMATION PROVIDED BY THE SURGEON/HOSPITAL, THE BROKEN PIN WAS NOT REMOVED FROM THE PATIENT'S BONE. PATIENT WAS DISCHARGED TO-DATE.
Patient problems: Foreign Body In Patient
MAUDE report 18946712 ↗InjuryMar 15, 2024Break; Fracture; Break; Fracture
THE FOLLOWING EVENT WAS RECEIVED THROUGH BFARM USER REPORT: "WHEN INSERTING THE FIXATOR PIN UNDER TYPICAL CONDITIONS, IT HAPPENED TWICE THAT BOTH PINS FROM THE SAME BATCH BROKE OFF IN EXACTLY THE SAME PLACE. THE REMNANTS HAD TO BE CHISELED OUT OF THE BONE. THE PREDETERMINED BREAKING POINT HAD TO BE BRIDGED. THESE ARE "SELF-TAPPING / SELF-DRILLING" PINS."
Patient problems: Perforation
MAUDE report 18911885 ↗InjuryMar 15, 2024Break; Fracture; Break; Fracture
THE FOLLOWING EVENT WAS RECEIVED THROUGH BFARM USER REPORT: "WHEN INSERTING THE FIXATOR PIN UNDER TYPICAL CONDITIONS, IT HAPPENED TWICE THAT BOTH PINS FROM THE SAME BATCH BROKE OFF IN EXACTLY THE SAME PLACE. THE REMNANTS HAD TO BE CHISELED OUT OF THE BONE. THE PREDETERMINED BREAKING POINT HAD TO BE BRIDGED. THESE ARE "SELF-TAPPING / SELF-DRILLING" PINS."
Patient problems: Perforation
MAUDE report 18911841 ↗MalfunctionDec 13, 2022Break; Fracture; Break; Fracture
AS REPORTED: "DOING AN EX-FIX CASE WITH A SURGEON, ONE OF THE STRYKER APEX PINS FROM THE HOFFMANN II COMPACT SET COULD NOT BE REMOVED FROM PATIENT. COULD HAVE BEEN SURGEON ERROR - OR PRODUCT ERROR, BUT WANTED TO REPORT NONETHELESS. APEX PIN WOULD NOT DISLODGE FROM PATIENT'S CALCANEOUS, ULTIMATELY ENDED UP SNAPPING TRYING TO REMOVE IT. BROKEN APEX PIN REMAINED INSIDE PATIENT." IT WAS ADDITIONALLY REPORTED THAT THERE WAS A SURGICAL DELAY OF UNKNOWN LENGTH.
Patient problems: Foreign Body In Patient
MAUDE report 15968436 ↗MalfunctionFeb 17, 2022Break; Fracture; Break; Fracture
THE CUSTOMER REPORTED THE FOLLOWING ISSUE: "WHEN INSERTING IN THE MOTOR A 5 MM FICHE DIAMETER OF THE HOFFMAN 3 IN ITS OWN GUIDE (THEY VERIFIED THAT THE GUIDE WAS THE CORRECT ONE FOR THE 5 MM DIAMETER), AFTER ABOUT 10 SECONDS THE SURGEON REPORTED AN OVERHEATING AND A BLOCKAGE OF THE FICHE IN THE GUIDE, AS IF A ¿MERGER¿ HAS HAPPENED." 1/21/2022 - ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: "THE PIN THAT GOT STUCK IN THE GUIDE (ONLY ONE HAPPENED, THEN I CHANGED THE TECHNIQUE) OBVIOUSLY HAS THE CODE COVERED, FOR THE OTHER PIN AS YOU CAN SEE FROM THE OTHER IMAGE IT HAPPENED THAT THE TIP BROKE, WHICH HAS NEVER HAPPENED TO ME BY HEART. I CONFIRM THAT I HAVE USED THE DRILL, I KNOW THAT THE TECHNIQUE DOES NOT PROVIDE THIS, BUT I HAVE BEEN IMPLANTING FIXATORS FOR 10 YEARS AND IT HAD NEVER HAPPENED TO ME THAT A PIN BROKE, IN THE CASE OF THE PIN THAT GOT STUCK IN THE GUIDE IT HAD ALREADY HAPPENED TO A COLLEAGUE OF MINE BUT THEN WE FORGOT TO REPORT IT TO YOU. THE PATIENT IS FINE, HE HAS ALREADY BEEN OPERATED FOR THE CONVERSION TO DEFINITIVE SYNTHESIS WITH SUCCESS, WE ONLY HAD A MODEST DILATION OF THE OPERATING TIMES. THE PROCEDURE, ALBEIT WITH DELAY, WAS SUCCESSFULLY COMPLETED. TO OVERCO
Patient problems: Foreign Body In Patient
MAUDE report 13552448 ↗MalfunctionJan 28, 2022Mechanical Jam; Mechanical Jam
THE CUSTOMER REPORTED THE FOLLOWING ISSUE: "WHEN INSERTING IN THE MOTOR A 5 MM FICHE DIAMETER OF THE HOFFMAN 3 IN ITS OWN GUIDE (THEY VERIFIED THAT THE GUIDE WAS THE CORRECT ONE FOR THE 5 MM DIAMETER), AFTER ABOUT 10 SECONDS THE SURGEON REPORTED AN OVERHEATING AND A BLOCKAGE OF THE FICHE IN THE GUIDE, AS IF A ¿MERGER¿ HAS HAPPENED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13388742 ↗MalfunctionJan 5, 2022Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User
AS REPORTED: "IN A CASE WHERE THE APEXPIN SHARP END SHOULD HAVE BEEN SHIPPED, THE BLUNT END WAS SHIPPED IN ERROR. FINALLY, ANOTHER COMPANY'S PRODUCT WAS USED, BUT THERE WAS A 30-MINUTE DELAY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13171448 ↗MalfunctionAug 13, 2021Fracture; Mechanical Jam; Fracture; Mechanical Jam
IT WAS REPORTED THAT WHEN INSERTING THE APEX PIN INTO THE TIBIAL DIAPHYSIS, THE SURGEON ATTACHED THE APEX PIN TO THE HANDPIECE AND TRIED TO INSERT IT INTO THE PATIENT'S BONE, BUT WHEN IT WAS INSERTED ABOUT 10MM, IT STOPPED PROGRESSING. THE APEX PIN BROKE AS SOON AS IT WAS CHANGED TO THE MANUAL INSERTION. SINCE THE TIP OF 10 MM REMAINED ON THE BONE, THE BROKEN TIP WAS REMOVED BY SCRAPING AROUND IT, THE BONE WAS SHAVED TO REMOVE THE PIN TIP. THE SURGERY WAS CONTINUED BY INSERTING THE APEX PIN IN ANOTHER POSITION.
Patient problems: Foreign Body In Patient
MAUDE report 12318870 ↗MalfunctionJul 29, 2021Break; Break
THE SURGEON HAD TO CONVERT INTRAOPERATIVELY FROM A MEDLINE ANKLE FRACTURE TO A STRYKER HOFFMANN EXTERNAL FIXATOR DUE TO PATIENT HAVING BLISTERS ON THEIR FOOT. THE SALES REP WAS NOT NOTIFIED. THE SURGEON PLACED 2 5MM X150MM APEX PINS IN THE PATIENTS RIGHT TIBIA. AFTER TRYING TO ADVANCE THE PIN THROUGH THE SECOND CORTICAL BONE AND NOT BEING ABLE TO, THE SURGEON THAN TRIED TO BACK THE APEX PIN OUT SO THAT HE COULD PRE-DRILL FOR THE PIN. THE SURGEON TRIED TO TAKE THE APEX PIN OUT FIRST WITH 4400 AND SYSTEM 7 POWER AND THAN BY HAND. WHILE THEY WERE USING THE HAND CRANK THE FIRST APEX PIN BROKE OFF WITH THE TIP STUCK IN THE PATIENTS TIBIA. THEY THEN MOVED TO THE SECOND APEX PIN AND TRIED THE SAME PROCEDURE IN WHICH THE SECOND APEX PIN BROKE OFF IN THE PATIENTS TIBIA AS WELL. THEY THEN PRE-DRILLED AND PLACED TWO NEW APEX PINS AND COMPLETED THE SURGERY WITH THE TWO BROKEN PIECES REMAINING IN THE PATIENTS BONE TO BE TAKEN OUT AT A LATER TIME.
Patient problems: Foreign Body In Patient
MAUDE report 12247219 ↗MalfunctionJul 29, 2021Break; Break
THE SURGEON HAD TO CONVERT INTRAOPERATIVELY FROM A MEDLINE ANKLE FRACTURE TO A STRYKER HOFFMANN EXTERNAL FIXATOR DUE TO PATIENT HAVING BLISTERS ON THEIR FOOT. THE SALES REP WAS NOT NOTIFIED. THE SURGEON PLACED 2 5MM X150MM APEX PINS IN THE PATIENTS RIGHT TIBIA. AFTER TRYING TO ADVANCE THE PIN THROUGH THE SECOND CORTICAL BONE AND NOT BEING ABLE TO, THE SURGEON THAN TRIED TO BACK THE APEX PIN OUT SO THAT HE COULD PRE-DRILL FOR THE PIN. THE SURGEON TRIED TO TAKE THE APEX PIN OUT FIRST WITH 4400 AND SYSTEM 7 POWER AND THAN BY HAND. WHILE THEY WERE USING THE HAND CRANK THE FIRST APEX PIN BROKE OFF WITH THE TIP STUCK IN THE PATIENTS TIBIA. THEY THEN MOVED TO THE SECOND APEX PIN AND TRIED THE SAME PROCEDURE IN WHICH THE SECOND APEX PIN BROKE OFF IN THE PATIENTS TIBIA AS WELL. THEY THEN PRE-DRILLED AND PLACED TWO NEW APEX PINS AND COMPLETED THE SURGERY WITH THE TWO BROKEN PIECES REMAINING IN THE PATIENTS BONE TO BE TAKEN OUT AT A LATER TIME.
Patient problems: Foreign Body In Patient
MAUDE report 12246509 ↗MalfunctionNov 13, 2020Fracture; Fracture
AS REPORTED: " 3 X STERILE APEX PINS REF NUMBER, (B)(4) WERE USED IN A NAVIGATED HIGH TIBIAL OSTEOTOMY CASE, INSERTED WITH A WIRED DRIVER, UPON REMOVAL WITH THE WIRE DRIVER POST FINISHING THE CASE IT WAS NOTED THAT THE TIPS OF THE PINS HAD BROKEN OFF. NOTICED AFTER SURGERY WAS COMPLETED AND REMOVING THE PINS."
Patient problems: Foreign Body In Patient
MAUDE report 10840129 ↗
Other Stryker GmbH products
All Stryker GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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