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	05/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "during the end cap procedure step, the end cap did not fit properly into the nail.At first a +10mm plug was used and did not fit the nail, and the +10mm plug was replaced with a +5mm plug because the threads of the +10mm plug might be the cause, but the +5mm plug did not fit the nail either.In the end, the surgery was completed without end caps.".
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.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.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.Without information a root cause could not be determined.With available information a product deficiency could not be determined.
Event or Problem Description
As reported: "during the end cap procedure step, the end cap did not fit properly into the nail.At first a +10mm plug was used and did not fit the nail, and the +10mm plug was replaced with a +5mm plug because the threads of the +10mm plug might be the cause, but the +5mm plug did not fit the nail either.In the end, the surgery was completed without end caps.".

• 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: 19513222
• Report Number: 0009610622-2024-00276
• Device Sequence Number: 7072850
• 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): 09/23/2024

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: K11D8A5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/16/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2023
• 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 Age: 70 YR
• Patient Sex: Male