MAUDE Adverse Event Report: STRYKER GMBH 2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM, AO COUPLING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	45-20001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/23/2019
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 not available for return.Disposed by hospital.
Event or Problem Description
Primary procedure, left condyle fracture of 1st metatarsal (great toe).It was reported that the tip of the cannulated driver broke off in the screw.The broken tip was removed using a pick-up, the wire removed, and a solid driver used to remove the screw.Fracture was addressed using a 3.0 wire.Surgery was completed successfully with a delay of approximately 1-2 minutes.

• Brand Name: 2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM, AO COUPLING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9587949
• Report Number: 0008031020-2020-00105
• Device Sequence Number: 3337342
• Product Code: LXH
• UDI-Device Identifier: 04546540534385
• UDI-Public: 04546540534385
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 01/14/2020

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 Catalogue Number: 45-20001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 01/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1