MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL KIT R1.5, TI, LEFT GAMMA3 Ø11X300MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	35251300S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	03/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "implant fracture after non-consolidated fracture.Explantation of the broken implant, implantation of a hip tep.".
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed as device was returned and matches to the alleged event.The returned device was visually inspected with the help of a microscope, revealing slight misdrilling marks on the distal end.There is significant deformation at the distal end, and small marks are also visible on the proximal end.This is confirmed by the notable signs of wear (shiny areas) around the lag screw hole and, more importantly, on the distal portion.The microscopic inspection revealed that the breakage originated on the lateral side of the nail.The presence of rest lines, a relatively smooth fracture surface on the initiation side, and abrupt features on the other side provide evidence of a fatigue fracture.Signs of a rapid fracture are visible in both the distal and proximal portions of the nail, indicating that the implant broke suddenly under high load.The shiny areas observed on the fracture surface result from friction between both portions during the breakage.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 broken nail was returned for evaluation and no product related issue could be detected.Neither x-rays, nor operation report, nor additional details about patient activity or medical history was available.Therefore the root cause of the breakage cannot be defined.The evaluation of the nail has shown that fatigue caused by high loads did lead to the breakage of the device.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "implant fracture after non-consolidated fracture.Explantation of the broken implant, implantation of a hip tep.".

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3 Ø11X300MM 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21960140
• Report Number: 0008031020-2025-00860
• Device Sequence Number: 20651242
• Product Code: HSB
• UDI-Device Identifier: 07613252274254
• UDI-Public: (01)07613252274254(17)280831(10)K17A987
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200869
• 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): 07/18/2025

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: 35251300S
• Device Lot Number: K17A987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2023
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 64 KG