MAUDE Adverse Event Report: STRYKER GMBH LOCKING COMPRESSION PLATE AXSOS 3 TI 10 HOLE / L136MM 4.0MM LOCKING; PLATE, FIXATION, BONE

Model Number	627510
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	12/09/2020
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 said : " operation on (b)(6) 2020 of a displaced fracture of the two bones of the right leg with a tibial axos plate.Leg support authorized at 2 months post-op on (b)(6) 2020.Satisfactory x-ray clinical check-up on (b)(6) 2020.Returns on (b)(6) 2020 for pain.Consequences : broken tibial plate at 4 months, no post-op infectious signs.Removal of the plate and screws including 4 locked screws.Osteosynthesis after bone harvesting.Endomedullary by plate screws on the tibia and fibula, resin plaster.".
Event or Problem Description
The customer said : " operation on (b)(6) 2020 of a displaced fracture of the two bones of the right leg with a tibial axos plate.Leg support authorized at 2 months post-op on (b)(6) 2020.Satisfactory x-ray clinical check-up on (b)(6) 2020.Returns on (b)(6) 2020 for pain.Consequences : broken tibial plate at 4 months, no post-op infectious signs.Removal of the plate and screws including 4 locked screws.Osteosynthesis after bone harvesting.Endomedullary by plate screws on the tibia and fibula, resin plaster.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.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.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: LOCKING COMPRESSION PLATE AXSOS 3 TI 10 HOLE / L136MM 4.0MM LOCKING
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11136241
• Report Number: 0008031020-2021-00013
• Device Sequence Number: 14377111
• Product Code: HRS
• UDI-Device Identifier: 07613327173833
• UDI-Public: 07613327173833
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2021

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 Model Number: 627510
• Device Catalogue Number: 627510
• Device Lot Number: D29155
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 04/15/2021
• 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