MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL KIT R1.5, TI, LEFT GAMMA3 Ø10X340MM X 130°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	35300340S
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	07/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Nail breakage occurred.A long gun nail was broken due to a pseudojoint.Revision surgery is planned.
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
Nail breakage occurred.A long gun nail was broken due to a pseudojoint.Revision surgery is planned.
Additional Manufacturer Narrative
The reported event could be confirmed, since the reporter provided a x-ray showing the nail 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.This event and the provided x-ray were forwarded to medical affairs, with the following review: unfortunately, we don¿t know they day of implantation, but the provided x-ray does show a non-union in an unstable sub trochanteric fracture of the femur.This can be due to several factors, usually a multifactorial combination (patient related but also technique related), a lack of stability, moving fracture parts which led to movement in the lag screw-nail interface and eventually to breakage.Based on the provided information, the root cause of the reported event is multifactorial: 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.Based on investigation, the root cause was attributed to patient condition-related factors (non-union).User-related factors, such as the chosen surgical technique, most probably also played a role in the lack of stability and therefore the device failure.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3 Ø10X340MM X 130°
• 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: 19929407
• Report Number: 0009610622-2024-00734
• Device Sequence Number: 11447147
• Product Code: HSB
• UDI-Device Identifier: 04546540375865
• UDI-Public: (01)04546540375865(11)220412(10)K022857
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2024

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: 35300340S
• Device Lot Number: K022857
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2022
• 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: 79 YR
• Patient Sex: Female