MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER BLADE, T10, AO; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	45-35015
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Tried to pull out the first screw manually at the time of operation of the navel clippers nail, the tip of the driver broke.Finished the procedure with a substitute driver.The broken tip was removed out of patient body.
Additional Manufacturer Narrative
The reported event that screwdriver blade, t10, ao 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 over torquing.The screwdriver blade was found to be broken from the tip.Microscopic inspection revealed a brittle fracture: the breakage is due to a torsional overload (too high torque applied).The fractured surface shows a peak that is surrounded by a diagonal fracture pattern.Such a fracture pattern is evident of fatigue failure due to high torsional load.In addition, marks of usages are visible on the device.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
Tried to pull out the first screw manually at the time of operation of the navel clippers nail, the tip of the driver broke.Finished the procedure with a substitute driver.The broken tip was removed out of patient body.

• Brand Name: SCREWDRIVER BLADE, T10, AO
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7784993
• Report Number: 0008031020-2018-00560
• Device Sequence Number: 19444738
• Product Code: LXH
• UDI-Device Identifier: 04546540540461
• UDI-Public: 04546540540461
• 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): 11/12/2018

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: 45-35015
• Device Lot Number: AH06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 08/15/2018
• Supplement Report FDA Received Date: 11/12/2018
• 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