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: 10631921
• Report Number: 0008031020-2020-02291
• Device Sequence Number: 3620330
• 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