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

Catalog Number	80040005S
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
As reported: the 5 mm end cap did not fit well, so a 0 mm end cap was used and the surgery was completed.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.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.In the case presented a patient (no data given) had been treated with above implant on (b)(6) 2024.It was reported the +5 mm end cap did not fit well, so a 0 mm end cap was used and the surgery was completed without delay, or adverse consequences.As the final choice of implant to be used is made intra-operatively and optimal fit is confirmed by x-ray it may happen that the surgeon is required to change an implant.In this case the initially chosen length of the end cap was too long for the anatomic situation which caused the surgeon to change to a shorter suitable one, which is a typical process.This change was performed without delay and / or without adverse consequences to the patient.The surgery was completed successfully.With available information a root cause was regarded as patient related.With available information a product deficiency was not verified.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: the 5 mm end cap did not fit well, so a 0 mm end cap was used and the surgery was completed.

• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19839597
• Report Number: 0009610622-2024-00716
• Device Sequence Number: 18080593
• Product Code: HSB
• UDI-Device Identifier: 07613327510973
• UDI-Public: 07613327510973
• 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): 11/07/2024

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: 80040005S
• Device Lot Number: K15A59D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2023
• 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