MAUDE Adverse Event Report: STRYKER GMBH END CAP GAMMA4 Ø15.5X5MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	80040005S
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "the device was implanted in orif for left femoral trochanteric fracture.There was no problem until 3 months after the surgery.When the patient visited the hospital on (b)(6) 2025, it was found that the end cap had dislodged about +5mm.The doctor decided to perform only follow-up monitoring as it would not affect bone healing".
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 device was implanted in orif for left femoral trochanteric fracture.There was no problem until 3 months after the surgery.When the patient visited the hospital in (b)(6) 2025, it was found that the end cap had dislodged about +5mm.The doctor decided to perform only follow-up monitoring as it would not affect bone healing".
Additional Manufacturer Narrative
Please note the correction to d4 gtin.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: END CAP GAMMA4 Ø15.5X5MM
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21440276
• Report Number: 0008031020-2025-00349
• Device Sequence Number: 4604353
• Product Code: HSB
• UDI-Device Identifier: 07613327510973
• UDI-Public: (01)07613327510973(11)231211(17)331130(10)K19050B
• 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): 04/04/2025

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: Lay User/Patient
• Device Catalogue Number: 80040005S
• Device Lot Number: K19050B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2025
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2023
• 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: Male