MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA 5X50 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1896-5050S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924); Implant Pain (4561)
Date of Event	11/18/2020
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.
Event or Problem Description
The customer reported that the gamma 3 femoral nail (right) broke at proximal end in-situ, just above lag screw hole.The nail has subsequently sunk and caused the distal locking screws to snap.This nail has been successfully extracted and revised.
Additional Manufacturer Narrative
Please note corrections to b1, h6 (clinical signs code and conclusion code).
Event or Problem Description
The customer reported that the gamma 3 femoral nail (right) broke at proximal end in-situ, just above lag screw hole.The nail has subsequently sunk and caused the distal locking screws to snap.This nail has been successfully extracted and revised.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned 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.The instructions for use instructs user that: ¿the surgeon must warn the patient that the device cannot and does not replicate a normal healthy bone, that the device can break or become damaged as a result of strenuous activity, trauma, mal-union or non-union and that the device has a finite expected service life and may need to be removed at some time in the future.Explain the need to report unusual changes in the implantation area as well as falls or accidents even if the device or the site of operation did not appear to be harmed at the time.Explain also the need to appear for the postoperative examinations (e.G.X-ray checks) and for the possible explantation of the implant.¿ more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, one of the possible causes of the failure is stumbling of the patient over a curb.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
The customer reported that the gamma 3 femoral nail (right) broke at proximal end in-situ, just above lag screw hole.The nail has subsequently sunk and caused the distal locking screws to snap.This nail has been successfully extracted and revised.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA 5X50 MM
• 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: 10996966
• Report Number: 0009610622-2020-00918
• Device Sequence Number: 19005445
• Product Code: HSB
• UDI-Device Identifier: 04546540202512
• UDI-Public: 04546540202512
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K032244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2021

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: 11/30/2024
• Device Model Number: 1896-5050S
• Device Catalogue Number: 18965050S
• Device Lot Number: K0864CC
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 01/20/2021; 02/18/2021
• Initial Report FDA Received Date: 12/12/2020
• Supplement Report FDA Received Date: 02/17/2021; 03/12/2021
• 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: 68 YR