MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - TROCHANTERIC NAIL 170MM D12X170MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81252170S
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	Stroke/CVA (1770); Respiratory Insufficiency (4462)
Date of Event	02/14/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "unable to unscrew bolt from the nail- tried everything, had to remove all implants from patient and put in gamma 3 nail.A gamma 3 11x180x125 nail was used to complete the surgery".
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The returned devices were received in jammed conditions.Visual examination revealed damage around the proximal lag screw hole, along with distinct misdrilling marks, indicating contact between the drill and the device during drilling.Damage was also observed at the end of the set screw.The damage patterns observed on the nail and set screw suggest exposure to very high forces during reaming.Additionally, possible overtightening of the device due to instability or loosening may have contributed to the occurrence of the reported event.The device was successfully disassembled using moderate additional force.Upon inspection after disassembly, no damage was observed at the interfaces or threaded regions, and all critical features were found to be in acceptable condition.Functional inspection confirmed normal device performance, as it could be repeatedly assembled and disassembled without difficulty, with components tightening and loosening as intended.Additionally, a functional test was conducted using a lag screw reamer, during which no anomalies were noted; the reamer passed freely through the hole without contacting or interfering with adjacent features.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required currently.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design-related problems were found during the investigation.Based on the available evidence, the most probable root cause of the disassembly impairment of the instruments intra-operatively is attributed to procedural or intraoperative mechanical conditions resulting in the application of elevated forces during device preparation and/or implantation steps.This is supported by the deformation of the set screw, localized damage near the lag screw hole, and the resistance encountered during disassembly.Based on the data provided at this point, there is no clear indication of a causal relationship between the device issue and the patient¿s outcome.The clinical course appears multifactorial and influenced by underlying patient condition and peri-operative factors if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "unable to unscrew bolt from the nail- tried everything, had to remove all implants from patient and put in gamma 3 nail.A gamma 3 11x180x125 nail was used to complete the surgery.The actual case was done within 45-60 mins.This was the last step (removing targeter) upon completion and this added about an hour to procedure.This meant 60 more minutes of open surgical wounds, redoing the procedure using gamma3, further blood loss (open wounds), higher risk of infection (prolonged time open wounds, open implants), and further time for a sick patient under anesthetic.Patient has since been re intubated for hypotension, respiratory failure and ischemic stroke post op day 1.Patient also has gone on to have further perioperative complications including ruptured esophagus, needing bilateral chest tubes.He remains in icu in critical condition.The patient unfortunately is deceased (b)(6), multi system organ failure.Autopsy declined by family ".

• Brand Name: GAMMA4 - TROCHANTERIC NAIL 170MM D12X170MM X 125DEG
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24670353
• Report Number: 0008031020-2026-00453
• Device Sequence Number: 17422631
• Product Code: HSB
• UDI-Device Identifier: 07613327479348
• UDI-Public: (01)07613327479348(17)350930(10)K14EC23
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 81252170S
• Device Lot Number: K14EC23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/14/2026
• Supplement Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Death
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Race: Black Or African American