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 Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	05/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "11 mm hammer nail with nail fracture in the area of the femoral head screw hole.This was a spontaneous fracture.Patient presented with pain.Revision surgery on 14.05.24 with 13 mm gamma nail and trochanteric hook plate.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "11 mm hammer nail with nail fracture in the area of the femoral head screw hole.This was a spontaneous fracture.Patient presented with pain.Revision surgery on (b)(6) 2024 with 13 mm gamma nail and trochanteric hook plate.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned broken as reported.The device inspection revealed the following: the received nail is completely broken in the webs of the proximal lag screw hole.Heavy material deformation can be seen on the web of distal end which most likely had created the starting point of the fracture at lateral.The lag screw bearing point shows strong impression marks and deformation which may come from high compressive load, indicating the nail was exposed to continuous high load over a long period of time.On the proximal side, instantaneous breakage can be seen at medial.There is a fatigue zone with a smooth surface and progression lines over almost the whole surface of the fracture.Therefore, the breakage pattern resembles a fatigue breakage of the nail.Furthermore, this event was forwarded to medical affairs for review, with the following result: "this is case of a subtrochanteric fracture, for which a long gamma nail was used.The reduction is not ideal, there seems to be a lack of compression on the fracture.It has to be said perfect reduction and compression are not easy to achieve for these fracture types especially using a mis approach.There was continuous movement in the construct due to a lack of stability, which resulted in stress on the lag screw-nail interface and eventually to implant breakage after 3,5 months.Based on the provided information, the root cause of the reported event is muti-factorial: the location of the fracture and the technical aspects of the surgical procedure may have contributed to the event.Furthermore, patient activity levels post-op, co-morbidities may also have contributed to an inadequate load distribution, and therefore the breakage of the implant." 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.If more information is provided, the case will be reassessed.

• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19515099
• Report Number: 0009610622-2024-00282
• Device Sequence Number: 16976152
• Product Code: HSB
• UDI-Device Identifier: 07613252274254
• UDI-Public: 07613252274254
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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: 35251300S
• Device Lot Number: K0FC109
• 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: 05/17/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2023
• 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: 82 YR
• Patient Sex: Female