MAUDE Adverse Event Report: STRYKER GMBH PROXIMAL LATERAL TIBIA PLATE TS AXSOS FOR RIGHT TIBIA 10 HOLE / L199MM; PLATE, FIXATION, BONE

Model Number	437330
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
"detected plate fracture in the removal procedure.".
Event or Problem Description
"detected plate fracture in the removal procedure".
Additional Manufacturer Narrative
Correction: refer to d9/h3, h6 results & conclusion codes.The reported event could be confirmed, although the affected device was not returned however an image of the broken plate was shared which confirms the alleged failure.A device inspection was not possible since the affected device was not returned, however an image of the broken plate was shared which confirms the alleged failure.However, nothing else could be deduced about the manner and likely cause of the breakage.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 manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More information like patient medical records as well as the affected device must be available to determine the exact root cause of the breakage.However, a probable cause of the failure could be an inadequate selection of the implant size for the given fracture, leading to such an early breakage.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device disposition is unknown.

• Brand Name: PROXIMAL LATERAL TIBIA PLATE TS AXSOS FOR RIGHT TIBIA 10 HOLE / L199MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11076939
• Report Number: 0008031020-2020-02606
• Device Sequence Number: 11516427
• Product Code: HRS
• UDI-Device Identifier: 07613154395705
• UDI-Public: 07613154395705
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K061012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 437330
• Device Catalogue Number: 437330
• Device Lot Number: F34608
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR