MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA 5X60 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1896-5060S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	06/30/2020
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 is not available; hospital retained.
Event or Problem Description
It was reported that the patient's right femur was revised due to the nail breaking at the junction of the lag screw, which then led to two distal screws breaking.Rep confirmed that no further information is available.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.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.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.General aspects: screw breakage in general has been experienced.It does not present an unanticipated event in itself.Depending on the load application, also, depending on the patient¿s post implant behaviour, on the suitable anatomical reduction, on the kind of bone breakage and depending on the course of bone healing and other factors a screw breakage can rather be classified as anticipated ¿ specifically if one or more contributing issues concurrence with each other.A successful treatment with an implant requires sufficient bone healing during the implantation period.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the patient's right femur was revised due to the nail breaking at the junction of the lag screw, which then led to two distal screws breaking.Rep confirmed that no further information is available.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA 5X60 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: 10329683
• Report Number: 0009610622-2020-00374
• Device Sequence Number: 2525934
• Product Code: HSB
• UDI-Device Identifier: 04546540202536
• UDI-Public: 04546540202536
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• 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
• Report Date (Section B): 09/22/2020

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: 06/30/2024
• Device Model Number: 1896-5060S
• Device Catalogue Number: 18965060S
• Device Lot Number: K0790E7
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 07/27/2020
• Supplement Report FDA Received Date: 09/22/2020
• 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: 71 YR
• Patient Weight: 60