MAUDE Adverse Event Report: STRYKER GMBH TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X200MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	31251200S
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	01/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "a broken nail was discovered.The nail had to be removed.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Please note corrections to section h6 (health impact code).The reported event could be confirmed, since the device was returned and matches the alleged failure.For available radiographs and operative notes, a formal medical opinion was sought: from the available information, the fracture reduction looks reasonable but the fracture will keep moving due to the lack of compression and stability, which will cause delayed/ non- union and implant failure in time.The received nail is completely broken in the webs of the proximal lag screw hole, in the proximal section slight misdrilling marks are also visible.We can see the load-bearing points on the proximal part of the broken nail which indicates overloading.Bearing points of the lag screw at the medial edge of the proximal hole showed significant deformation, indicating the high compressive load.Signs of overloading were also evident at the distal oblong hole.The breakage pattern resembles a fatigue breakage, having equal portions of fatigue zone and instantaneous zone indicating that the breakage was initiated in a fatigued manner but quickly broke instantaneously under high compressive loading.We also observed deformation at the distal hole which was caused by to misalignment of a drill during the process.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.Based on investigation, the root cause of the reported event is muti-factorial.The location of the fracture, the choice of the implant given that location, and the patient activity levels post-op may have contributed to an inadequate load distribution, and therefore the breakage of the implant.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
A broken nail was discovered.The nail had to be removed.2/5/2024 - additional information received.Nail fracture in conjunction with delayed fracture healing in status post gamma nail osteosynthesis due to subtrochanteric fracture of the right femur.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X200MM 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: 18639771
• Report Number: 0009610622-2024-00055
• Device Sequence Number: 18083312
• Product Code: HSB
• UDI-Device Identifier: 04546540375087
• UDI-Public: 04546540375087
• 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: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2024

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: 31251200S
• Device Lot Number: K16BD04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 02/05/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2023
• 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 Sex: Male
• Patient Weight: 100 KG