MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3 11X320MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3525-1320S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	03/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported, after x-rays, it was discovered, 4 months after the implantation, the breakage of the nail, at lag screw intersection and a total hip replacement has been performed.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the reported failure mode.As per the visual inspection, the received gamma3 nail was found to be broken around the proximal region at the point of lag screw insertion hole.The microscopic images indicate this to be a fatigue fracture.The point of origin is clearly visible in the microscopic images.Fatigue fractures occur under repeated or fluctuating stresses.The maximum stress in a part is less than the yield strength of the material.Fatigue fractures begin as a microscopic crack or cracks that grow as force is applied repeatedly to a part.When the load is high, the number of required cycles for the part to finally break is low.Fatigue fractures don¿t require high stress, so there is usually very little deformation.The lag screw received shows intense traces of use [high axial load bearing].The material deformation was generated by friction between lag screw and nail related to the high axial load application.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.Based on the investigation, the root cause of the failure is predominantly user related as during visual inspection, the severe drill marks are visible on nail near lag screw insertion hole and the operative technique also states the warning ¿in the event the nail is damaged during lag screw reaming, the fatigue strength of the implant may be reduced, which may cause nail to fracture.¿ which along with patient factor (age 88 years i.E.High chances of having osteopenia) would have resulted in nail breakage.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported, after x-rays, it was discovered, 4 months after the implantation, the breakage of the nail, at lag screw intersection and a total hip replacement has been performed.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3 11X320MM 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: 9988705
• Report Number: 0009610622-2020-00158
• Device Sequence Number: 4597764
• Product Code: HSB
• UDI-Device Identifier: 07613252274261
• UDI-Public: 07613252274261
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2020

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: 05/31/2023
• Device Model Number: 3525-1320S
• Device Catalogue Number: 35251320S
• Device Lot Number: K036E31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2020
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 07/15/2020
• 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: 88 YR