MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X340MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3525-1340S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924); Injury (2348); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/24/2020
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
It was reported, a patient fell over & fractured left neck of femur.Already had a long gamma nail in hip which fractured at site of lag screw.Operation for removal of broken nail & insertion of 13 mm long gamma nail.
Additional Manufacturer Narrative
The reported event could be confirmed, although the device was not returned for evaluation; photographs and an x-ray image were provided as part of the investigation.A review of the provided picture and post-operative x-ray confirmed the nail was completely broken from the webs of proximal hole.Based on the provided x-ray, a medical opinion was sought from the medical expert, but no conclusive statement or opinion could be made due to insufficient information.¿it is very likely, that non-union led to permanent load on the nail and then breakage occurred.Subtrochanteric fracture with quite a high rate of expected non-union.Difficult to say without further x-rays.¿ additional information was provided by the customer where the patient¿s bone quality was deemed osteoporotic and malunion of bone also occurred.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.Through the provided information, the exact root cause could not be determined.However, one of the probable root causes would be, but not limited to: non-union which led to permanent load on the nail and then breakage occurred and patient factor (osteoporotic bone).A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported, a patient fell over & fractured left neck of femur.Already had a long gamma nail in hip which fractured at site of lag screw.Operation for removal of broken nail & insertion of 13mm long gamma nail.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X340MM 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; DE D-24232
• MDR Report Key: 9721683
• Report Number: 0009610622-2020-00059
• Device Sequence Number: 10845164
• Product Code: HSB
• UDI-Device Identifier: 07613252274278
• UDI-Public: 07613252274278
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2020

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: 08/31/2023
• Device Model Number: 3525-1340S
• Device Catalogue Number: 35251340S
• Device Lot Number: K0F032D
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2020
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 04/02/2020
• 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: 87 YR
• Patient Weight: 53