MAUDE Adverse Event Report: STRYKER GMBH 3.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 3.0MM, AO COUPLING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	45-30001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
When screwing in the asnis screw, the tip of the screwdriver blade is broken off.Surgical delay of 20 min.Not longer.Device is part of consignment.Replacement was available.
Additional Manufacturer Narrative
The reported event that 3.0mm asnis micro, cannulated screwdriver, 3.0mm, ao coupling was alleged of 'breakage during surgery' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by too much torsinal force during screw insertion.The device inspection revealed the following: the tip of the returned screwdriver is completely broken off.Unfortunately no further detailed information could be obtained which would point to a possible explanation of the breakage.The close up views, done by the microscope, indicating that the surface of the breakage is homogenous which again indicate conformity to the given specification.The root cause of the failure could be found due to repeated powerful dynamically overload during use.The device was manufactured in nov.2015.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
Event or Problem Description
When screwing in the asnis screw, the tip of the screwdriver blade is broken off.Surgical delay of 20min.Not longer.Device is part of consignment.Replacement was available.

• Brand Name: 3.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 3.0MM, AO COUPLING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8246084
• Report Number: 0008031020-2019-00022
• Device Sequence Number: 19380554
• Product Code: LXH
• UDI-Device Identifier: 04546540534446
• UDI-Public: 04546540534446
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2019

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: 45-30001
• Device Lot Number: AI11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other