MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3 10X360MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3525-0360S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	02/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device retained by the hospital.
Event or Problem Description
As reported: "patient fell, gamma nail broke at lag screw junction." patient was revised to a gmrs proximal femur with bipolar.Additional info received from the representative (b)(6) 2021: doctor has indicated that the ¿pathologic fracture w radiation, bone never healed, pathologic non-union¿.
Additional Manufacturer Narrative
The reported event could be confirmed, although the device was not returned but an x-ray was shared which confirms the reported failure mode.A device inspection was not possible since the affected device was not returned, and no other evidences were provided for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.A formal medical opinion was sought from an independent medical professional based on the single x-ray provided, but with the limited amount of information it was not possible ascertain the exact scenario.He opined that looking at the x-ray it did appear that the fracture did not heal.It wasn¿t clearly informed about the disease which caused the pathologic fracture, it may have been cancer related since radiation is mentioned.Within the given timeframe, the fracture should have been healed.Patients with pathologic fractures the non-union rate is higher and there is always a risk that the implant might fail in this patient group if the patient lives long enough.Although the available information indicates that the nail breakage happened due to the alleged fall of the patient and the alleged pathological nonunion, both of which are patient related factors, but still more patient information, radiographs, medical history and the affected device must be available in order to determine the exact root cause of the failure, if the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "patient fell, gamma nail broke at lag screw junction." patient was revised to a gmrs proximal femur with bipolar.Additional info received from the representative 02/17/2021: doctor has indicated that the ¿pathologic fracture w radiation, bone never healed, pathologic non-union¿.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3 10X360MM X 125
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 11426288
• Report Number: 0009610622-2021-00332
• Device Sequence Number: 3243096
• Product Code: HSB
• UDI-Device Identifier: 04546540375742
• UDI-Public: 04546540375742
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2021

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 Expiration Date: 01/31/2022
• Device Model Number: 3525-0360S
• Device Catalogue Number: 35250360S
• Device Lot Number: K0CFBE6
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 59