MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA 4X40 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1896-4040S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	06/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
A patient who had an operation at the (b)(6) medical center last year was discharged from the hospital and then re-fractured and was admitted to the municipal (b)(6) hospital.Two of the three t2gtn distal screws broke.The doctor diagnosed nonunion and performed revision surgery.
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 device inspection was not possible since the affected device was not returned, and no other evidences were provided 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.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, based on past complaints, the most probable root cause of the failure could be due to non-union of the bone causing overloading of the nail and subsequently screws as well, leading to breakage.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
A patient who had an operation at the (b)(6) medical center last year was discharged from the hospital and then re-fractured and was admitted to the (b)(6) hospital.Two of the three t2gtn distal screws broke.The doctor diagnosed nonunion and performed revision surgery.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA 4X40 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: 12068849
• Report Number: 0009610622-2021-00580
• Device Sequence Number: 3926622
• Product Code: HSB
• UDI-Device Identifier: 04546540202406
• UDI-Public: 04546540202406
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K003018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

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: No Information
• Device Expiration Date: 12/31/2024
• Device Model Number: 1896-4040S
• Device Catalogue Number: 18964040S
• Device Lot Number: K0C6BD2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 06/25/2021
• Supplement Report FDA Received Date: 08/26/2021
• 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: 76 YR