MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL KIT R1.5, TI, LEFT GAMMA3 Ø13X400MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	35253400S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "gamma nail broke at lag screw junction".Additional information received: patient underwent revision surgery (b)(6) 2024, exchanged broken nail with smith & nephew 13x400mm interstrain nail.
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Additional Manufacturer Narrative
Correction - please refer to d1 product long description, d4 (catalog, lot,).The reported event could be confirmed, since the nail is broken apart as described in the event description.The device inspection revealed the following: the returned nail is broken apart at the lag screw hole.During the microscopic inspection the typical characteristics of a fatigue fracture could be identified on both fracture faces.There is a fatigue zone with a smooth surface and progression lines on almost the whole fracture face which ends in a rougher instantaneous zone, where the nail finally broke apart.There is a strong deformation at the fracture initiation point visible, but in retrospective it cannot be defined if this damage occurred during reaming or after the breakage by a strong contact with the lag screw.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.The complaint was forwarded to medical affairs for review with following result: within 6 weeks of implantation there is a significant back-out of one of the distal screws.This back-out could be an indication for movement within the construct.This is also indicated by the subsequent breakage of the migrated locking screw, as it seems that the screw was pushed downwards after the back-out, which did lead to high shear forces and finally the failure of the screw.The back-out of the screw, where the screw is clearly no longer in the second cortex, has affected the stability of the construct even more.More movement in the construct will also affect the proximal side, the lag screw-nail interface.Since there is insufficient stability the loads on the interface became a problem, which did lead to the nail breakage.No product related issue could be detected.The implants could finally not resist the applied force which finally led to the material overload fatigue failure.Based on the provided information, the root cause of the reported event is multi-factorial: the location of the fracture and the technical aspects of the surgical procedure 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.
Event or Problem Description
As reported: "gamma nail broke at lag screw junction".Additional information received: patient underwent revision surgery (b)(6) 2024, exchanged broken nail with smith & nephew 13x400mm intertan nail.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3 Ø13X400MM 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: 20972613
• Report Number: 0009610622-2024-00961
• Device Sequence Number: 8602284
• Product Code: HSB
• UDI-Device Identifier: 04546540409935
• UDI-Public: (01)04546540409935(17)281231(10)K19907F
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2025

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: 35253400S
• Device Lot Number: K19907F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2024
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 63 KG