MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW, FULLY THREADED T2 Ø5X45 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18965045S
Medical Device Problem Codes	Break (1069); Fracture (1260); Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device inspection revealed the following: the inspection of the returned 45mm locking screw has shown that a piece of the screw is broken off.The broken fragment was not returned for evaluation, based on the provided x-ray from the revision surgery it looks like the fragment was left in the patient.The remaining thread flanks are partially flattened, which was most likely caused by an excessive contact with the nail during the insertion because there is a strong stress at the corresponding nail hole visible.The typical characteristics of a fatigue fracture could also be identified on this fracture face during the microscopic inspection.There is a fatigue zone with a smooth surface and progression lines over almost the whole surface which ends in an small instantaneous zone with a fine shear lip, where the screw finally broke apart.The review of the received 6 weeks post-operative x-rays has shown an in-situ migration of the screw.On the 14 weeks post-operative x-rays it visible that the migrated screw was pushed downwards and that the full load from the nail was applied on the upper edge of the bore, where finally the breakage of the screw occurred.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
Broken long gamma nail.Additional information received: patient underwent revision surgery (b)(6) 2024, exchanged broken nail with smith & nephew 13x400mm intertan nail.Updated information: during the review of the x-rays the screw that was found to be broken during the investigation, was migrated 6 weeks post-operative.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 Ø5X45 MM
• 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: 21531745
• Report Number: 0008031020-2025-00375
• Device Sequence Number: 7857444
• Product Code: HSB
• UDI-Device Identifier: 04546540202505
• UDI-Public: (01)04546540202505(17)290531(10)K1BDA24
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K032244
• 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
• Report Date (Section B): 03/05/2025

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
• Device Catalogue Number: 18965045S
• Device Lot Number: K1BDA24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2024
• 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