MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT, AO DIA2.0MM X 135MM, SCALED; PLATE, FIXATION, BONE

Catalog Number	703690
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/23/2018
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
It was reported by the distributor that surgeon perform drilling with 2.0 drill bit and it was broken.Surgeon asked for the same said drill bit and performed second drilling, and it was broken again.X-ray showed the drill bits were broken in the bone and drill bits were not removed.
Event or Problem Description
It was reported by the distributor that surgeon perform drilling with 2.0 drill bit and it was broken.Surgeon asked for the same said drill bit and performed second drilling, and it was broken again.X-ray showed the drill bits were broken in the bone and drill bits were not removed.
Additional Manufacturer Narrative
The reported event that drill bit, ao dia2.0mm x 135mm, scaled 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 overtorquing the drill bit.The device inspection revealed the tip of the drill is broken.Microscopic inspection revealed a brittle fracture: the breakage is due to a torsional overload (too high torque applied).In addition, marks of usages are visible on the device and flutes are blunt.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: DRILL BIT, AO DIA2.0MM X 135MM, SCALED
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7606384
• Report Number: 0008031020-2018-00467
• Device Sequence Number: 16549977
• Product Code: HRS
• UDI-Device Identifier: 07613327069853
• UDI-Public: 07613327069853
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K170727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2018

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: 703690
• Device Lot Number: 6000066797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Initial Date Received by Manufacturer: 05/23/2018
• Supplement Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 10/24/2018
• 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