MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL, LEFT GAMMA4 Ø12X380MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	85252380S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	09/10/2024
Type of Reportable Event	Serious Injury
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
It was reported that a patient was revised because postoperatively the gamma4 long nail was broken and requires a revision.Revision surgery is planned on (b)(6).
Additional Manufacturer Narrative
The reported event could be confirmed, since nail breakage could be observed on 2 provided x-rays.A product inspection was not performed because the product was not provided.It could not be determined if the implant had been damaged intra-operatively.A review of the device history for the reported lot did not indicate any abnormalities.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.No corrective actions are required at this time.If the device is returned or if any essential information is provided, the investigation will be reassessed.In the case presented a 53-year-old male patient had been treated with above product on (b)(6) 2024.On (b)(6) 2024, it was determined the item had broken.The item was removed on (b)(6) 2024.It was reported after 3 weeks partial load bearing was allowed.The patient walked by himself but was compliant to the surgeon¿s mobilization instruction.We received 2 undated x-rays in a-p- and m-l-view showing the broken nail.The bone fracture gap was still visible.Further information was not provided.A medical professional reviewed the x-rays and came to the conclusion that the bone had not healed after approx.Months of implantation.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.Based on investigation, the root cause was attributed to a patient related issue.
Event or Problem Description
It was reported that a patient was revised because postoperatively the gamma4 long nail was broken and requires a revision.Revision surgery is planned on (b)(6).

• Brand Name: LONG NAIL, LEFT GAMMA4 Ø12X380MM 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: 20392451
• Report Number: 0009610622-2024-00853
• Device Sequence Number: 8065929
• Product Code: HSB
• UDI-Device Identifier: 07613327475234
• UDI-Public: 07613327475234
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2025

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: 85252380S
• Device Lot Number: K143F8B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male