MAUDE Adverse Event Report: STRYKER GMBH K-WIRE, LARGE OLIVE, THREADED AXSOS 3 AF 1.6MM / L65MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	705800
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2020
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 was discarded.
Event or Problem Description
Surgeon performed a tibio-calcaneal joint fusion with use of an anterior standard plate and additional fixation material.Her feedback included the following: ¿all 3 olives broke above the olive.¿ indicated as an identified area for improvement for available instruments.Sales representative additionally reported that the event occurred "during the extraction from the plate.I think they had the driver in forward and the torque snapped it.".

• Brand Name: K-WIRE, LARGE OLIVE, THREADED AXSOS 3 AF 1.6MM / L65MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10631887
• Report Number: 0008031020-2020-02293
• Device Sequence Number: 3620329
• Product Code: LXH
• UDI-Device Identifier: 07613327409666
• UDI-Public: 07613327409666
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 10/05/2020

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: 705800
• Device Catalogue Number: 705800
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 10/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1