MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1896-5045S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	01/20/2020
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
The customer reports a breakage of the nail.X-rays showed that the locking screws were also broken.A revision surgery was performed.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the reported failure mode.The received device inspection revealed the following: the received screws were broken in the mid shaft region.The breakage surface of the broken locking screw shows features of a fatigue fracture such as smooth topography and lines of rest.Plastic deformation was not found.Damage found at the thread of the locking screws such as considerable friction signs resp.Bearing points indicate high axial load application, as well.The thread flanks of both locking screws are significantly flattened.Based on the provided medical records, the medical opinion was sought from experienced independent medical expert which revealed the following; ¿due to non-union first the screws broke as a result of ¿self-mobilization¿ and compression, when the non-union prolonged, the nail broke.¿ 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 was attributed to a patient related issue.The failure was caused due to nonunion which leads to high axial load application.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The customer reports a breakage of the nail.X-rays showed that the locking screws were also broken.A revision surgery was performed.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 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; DE D-24232
• MDR Report Key: 9813235
• Report Number: 0009610622-2020-00096
• Device Sequence Number: 10923418
• Product Code: HSB
• UDI-Device Identifier: 04546540202505
• UDI-Public: 04546540202505
• Combination Product (Y/N): N
• PMA/510(K) Number: K032244
• 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): 04/29/2020

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: 02/29/2024
• Device Model Number: 1896-5045S
• Device Catalogue Number: 18965045S
• Device Lot Number: K02A865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 04/29/2020
• 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: 67 YR