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

Catalog Number	45-20001
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2019
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
As reported: "broken tip of the driver when inserting the screw.The broken part remained in the body and removed it about 1 hour for extraction.There is also a possibility that remains even in the roentgen confirmation.".
Additional Manufacturer Narrative
Correction: sections d10 (concomitant medical products), h3 (device evaluated by mfr).The reported event could not be confirmed, since the device was not returned and no other evidence was provided.A review of the device history was not possible as the lot number was not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device not available.
Event or Problem Description
As reported: "broken tip of the driver when inserting the screw.The broken part remained in the body and removed it about 1 hour for extraction.There is also a possibility that remains even in the roentgen confirmation.".

• 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: 8935582
• Report Number: 0008031020-2019-01156
• Device Sequence Number: 13499895
• Product Code: LXH
• UDI-Device Identifier: 04546540534385
• UDI-Public: 04546540534385
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 10/29/2019

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
• Date Returned to Manufacturer: 08/20/2019
• Initial Date Received by Manufacturer: 08/02/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1