MAUDE Adverse Event Report: STRYKER GMBH RC LAG SCREW GAMMA4 Ø10.5X85MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81660085S
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Fracture (1260); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
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
During gamma 4 surgery, the lag screw replacements occurred twice.The first time, when a u-lag screw (8166-0080s) of the value obtained at the time of measurement was inserted, it was placed in a shorter position than expected.The u-lag screw (8166-0085s), one size longer, was replaced and reinserted.The length was fine, but when compression was applied intraoperatively, compression was not applied as expected.The compression operation was stopped midway and the u-blade was inserted.After that, during blade insertion the blade was bent.When the blade was removed, the blade was broken in the middle.Finally, the surgery was successfully completed by replacement to a regular lag screw (8160-0085s), instead of using the u-lag screw.
Additional Manufacturer Narrative
Correction : please refer h6 - health impact code.The reported event could not be confirmed as device was not returned and no other evidence were 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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
During gamma 4 surgery, the lag screw replacements occurred twice.The first time, when a u-lag screw (8166-0080s) of the value obtained at the time of measurement was inserted, it was placed in a shorter position than expected.The u-lag screw (8166-0085s), one size longer, was replaced and reinserted.The length was fine, but when compression was applied intraoperatively, compression was not applied as expected.The compression operation was stopped midway and the u-blade was inserted.After that, during blade insertion the blade was bent.When the blade was removed, the blade was broken in the middle.Finally, the surgery was successfully completed by replacement to a regular lag screw (8160-0085s) instead of using the u-lag screw.

• Brand Name: RC LAG SCREW GAMMA4 Ø10.5X85MM
• 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: 20748448
• Report Number: 0009610622-2024-00920
• Device Sequence Number: 8287814
• Product Code: HSB
• UDI-Device Identifier: 07613327591798
• UDI-Public: (01)07613327591798(17)340731(10)K1C9354
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K230512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2024

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: 81660085S
• Device Lot Number: K1C9354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/24/2024
• 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