MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - TROCHANTERIC NAIL 170MM D10X170MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81250170S
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "because the lag screw was shorter, the surgeon replaced it with longer one.At that time, the set screw was loosened once, and after the lag screw was replaced, the surgeon attempted to tighten the set screw again.However, the set screw wouldn't tighten.Thus, the whole nail was removed from the patient and new nail was opened and was used to complete the procedure.No patient injuries occurred, but the operation time was extended by 30 minutes to replace the nail.The surgeon tried to tighten the set screw again outside of patient's body using the removed nail, and it would tightened.When he tried to do this several times, sometimes it wouldn't tighten.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was returned for evaluation and observed to be functional after proper assembly of the locking pin, set screw and nail.The returned device was visually inspected, during which we observed that the locking pin and the set screw are out of the nail, which are pre-inserted in the nail.At its designated location, we also see slight scratch marks on the set screw, indicating that it was used.A functional inspection was conducted in which the locking pin was tried to be inserted inside the nail; it was noted if the alignment of the locking pin, nail as to be aligned with proper contour of nail medial and lateral.The slight groove on nail for proper insertion.While assembly all the three parts it was noted if the assembly is improper than the set screw will keep on moving freely, but when assembly was done properly set screw was found functional in nature.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.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 above investigation, the root cause could be determined to user-related as the device was found to be functional after proper assembly of locking pin, which is provided as the pre-inserted into the new nail.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "because the lag screw was shorter, the surgeon replaced it with longer one.At that time, the set screw was loosened once, and after the lag screw was replaced, the surgeon attempted to tighten the set screw again.However, the set screw wouldn't tighten.Thus, the whole nail was removed from the patient and new nail was opened and was used to complete the procedure.No patient injuries occurred, but the operation time was extended by 30 minutes to replace the nail.The surgeon tried to tighten the set screw again outside of patient's body using the removed nail, and it would tightened.When he tried to do this several times, sometimes it wouldn't tighten.".

• Brand Name: GAMMA4 - TROCHANTERIC NAIL 170MM D10X170MM 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 TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22613758
• Report Number: 0008031020-2025-01303
• Device Sequence Number: 21233292
• Product Code: HSB
• UDI-Device Identifier: 07613327479058
• UDI-Public: (01)07613327479058(17)350228(10)K11442C
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 81250170S
• Device Lot Number: K11442C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2025
• 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
• Patient Sex: Female