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	06/20/2019
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
It was reported that when the 2.0 asnis mircro cannulated screw driver was advanced over guide wire, the tip of the driver was broken.Therefore, it was changed the new same ones, but same event was occurred.Finally, the screw was implanted with solid drill.The broken piece of the driver was removed from the patient body.
Event or Problem Description
It was reported that when the 2.0 asnis mircro cannulated screw driver was advanced over guide wire, the tip of the driver was broken.Therefore, it was changed the new same ones, but same event was occurred.Finally, the screw was implanted with solid drill.The broken piece of the driver was removed from the patient body.
Additional Manufacturer Narrative
The reported event could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by too much applied mechanical force during screw insertion.The device inspection revealed the following: the tips of the two returned devices are indeed completely broken off (manufactured in sept.2010 & april 2018).The microscope analysis indicate that the surface of the breakages are homogenous which indicates a sudden breakage of the device.This could be due to high applied forces which led to a strain of the material and finally resulted in the breakage during screw insertion.As a result, the root cause of the failure was considered to be repeated powerful dynamic overloading during use (possibly hard bone) especially as it was mentioned that one tip broke right after the other.Unfortunately no further detailed information could be obtained.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.

• 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: 8804440
• Report Number: 0008031020-2019-00883
• Device Sequence Number: 18912359
• 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): 09/26/2019

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: AA08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Received by Manufacturer: 06/21/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1