MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL, RIGHT GAMMA4 Ø12X400MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	84252400S
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "orif was performed for a male patient with right femoral trochanteric fracture.After tightening the set screw, the surgeon found that the bone head could be rotated while the nail was implanted.Thus, the surgeon attempted to loosen the set screw to adjust the rotational alignment by the lag screw.However, the set screw was not loosened even though the surgeon tried to turn it both clockwise and counterclockwise.Eventually, the lag screw began to turn slightly, so the surgeon completed the surgery by adjusting the lag screw and retightened the set screw while the set screw did not turn smoothly even after adjusting the lag screw.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences 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.In relation to the set screw insertion following statement of the gamma4 hip fracture nailing system operative technique can be pointed out: "warning ensure the lag screw driver handle is parallel or perpendicular to the proximal targeting arm.Take care during set screw insertion to avoid any implant damage.This may compromise implant performance." if the device is returned or if any additional information is provided, the investigation will be reassessed.
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: "orif was performed for a male patient with right femoral trochanteric fracture.After tightening the set screw, the surgeon found that the bone head could be rotated while the nail was implanted.Thus, the surgeon attempted to loosen the set screw to adjust the rotational alignment by the lag screw.However, the set screw was not loosened even though the surgeon tried to turn it both clockwise and counterclockwise.Eventually, the lag screw began to turn slightly, so the surgeon completed the surgery by adjusting the lag screw and retightened the set screw while the set screw did not turn smoothly even after adjusting the lag screw.".

• Brand Name: LONG NAIL, RIGHT GAMMA4 Ø12X400MM X 125°
• 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: 19522343
• Report Number: 0009610622-2024-00284
• Device Sequence Number: 8412776
• Product Code: HSB
• UDI-Device Identifier: 07613327476040
• UDI-Public: 07613327476040
• 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): 08/15/2024

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: 84252400S
• Device Lot Number: K156B11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2023
• 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