MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL, RIGHT GAMMA4 Ø10X360MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	84250360S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369); Implant Pain (4561)
Date of Event	11/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "the surgeon reports what he believes to be a broken gamma 4 nail.The surgeon claims again that the nail broke at the junction of the lag screw.There has not to date been a re operation.".
Event or Problem Description
As reported: "the surgeon reports what he believes to be a broken gamma 4 nail.The surgeon claims again that the nail broke at the junction of the lag screw.There has not to date been a re operation." update: the patient claims they had little to no pain for 6 months then suddenly felt pain.The nail was explants and the surgeon implanted a total hip replacement.
Additional Manufacturer Narrative
Please note the corrections to b5, d4 gtin, h6 health impact and h6 method codes.The reported event could be confirmed since the device was not returned for evaluation but with provided images and radiographs confirm the alleged event.A device inspection was not possible since the affected device was not returned but with the available pictures the breakage of the nail was confirmed but the actual device is required for breakage surface and root cause analysis.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.With the available radiograph, a medical opinion was sought with the limited information where the pre-op x-rays are missing and the second direction is missing, it is difficult to provide details on the stability of the construct because we cannot see the distal end and thus the way the nail was fixed there.Furthermore, pre- and post- op x-rays are missing in two directions and time stamps are also not available.Based on the time that passed and the provided x-ray, there is a non-union.There is hardly any callus formation, and the fracture line is still visible on the x-ray on the lateral and the medial side of the nail.This can be seen on the x-ray where the nail was still intact.The exact root cause cannot be defined as non-unions are in general multifactorial.The location and pattern of the fracture, biology, and the technical aspects of the surgical procedure have contributed to the event.Furthermore, patient activity levels post-op may also have contributed to an inadequate load distribution, and therefore the breakage of the implants.If more information is provided, the case will be reassessed.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: LONG NAIL, RIGHT GAMMA4 Ø10X360MM 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: 20897132
• Report Number: 0009610622-2024-00948
• Device Sequence Number: 5004598
• Product Code: HSB
• UDI-Device Identifier: 07613327479447
• UDI-Public: (01)07613327479447(17)321031(10)K03325A
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 84250360S
• Device Lot Number: K03325A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2024
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female