MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - END CAP D11X0MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	80040000S
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "the end cap has become loosed 2 weeks after the operation conducted on (b)(6) 2026.There is no plan of a revision surgery.".
Additional Manufacturer Narrative
The reported event could be confirmed although the device was not returned but a few x-rays were shared which confirms the alleged event.A device inspection was not possible since the affected device was not returned.However, a few x-rays were shared which confirms loosening of the end cap.The end cap appears to be dislodged from the nail but still in close proximity to it.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.With the available information and x-rays, a definitive root cause of the issue could not be determined.More information as well as the affected device must be available in order to determine the exact root cause of the issue.If the device is received or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the end cap has become loosed 2 weeks after the operation conducted on (b)(6) 2026.There is no plan of a revision surgery.".

• Brand Name: GAMMA4 - END CAP D11X0MM
• 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 GMBH; 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: 24513891
• Report Number: 0008031020-2026-00362
• Device Sequence Number: 8430653
• Product Code: HSB
• UDI-Device Identifier: 07613327510980
• UDI-Public: (01)07613327510980(17)350831(10)K148C81
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2026

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: Lay User/Patient
• Device Catalogue Number: 80040000S
• Device Lot Number: K148C81
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2025
• 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 Age: 86 YR
• Patient Sex: Female