MAUDE Adverse Event Report: STRYKER GMBH PROXIMAL LATERAL TIBIA PLATE AXSOS 3 TI FOR RIGHT TIBIA 2 HOLE / L95MM; PLATE, FIXATION, BONE

Model Number	627332
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
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 for return, device is still implanted.
Event or Problem Description
It was reported, a doctor threaded a 70mm fully threaded 4.0 x 70mm cancellous axsos 3 screw entirely through the proximal hole of the plate where the targeter for distal screws attaches.Remained implanted.

• Brand Name: PROXIMAL LATERAL TIBIA PLATE AXSOS 3 TI FOR RIGHT TIBIA 2 HOLE / L95MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9613206
• Report Number: 0008031020-2020-00110
• Device Sequence Number: 2677416
• Product Code: HRS
• UDI-Device Identifier: 07613252579434
• UDI-Public: 07613252579434
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K181091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/21/2020

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: Health Professional
• Device Model Number: 627332
• Device Catalogue Number: 627332
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/01/2020
• Initial Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR