MAUDE Adverse Event Report: STRYKER GMBH TWIST DRILL, DIAM.2.0X102MM, WL 50MM, AO-SHAFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	45-27010
Health Effect - Clinical Code	Perforation (2001)
Date of Event	09/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The tip of the drill breaks during operation of the skull distal osteosynthesis.The drill passed through the skin on the other side.
Additional Manufacturer Narrative
The reported event that twist drill, diam.2.0x102mm, wl 50mm, ao-shaft 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 possible inadequate angulation and too much applied force of the drill bit.The device inspection revealed the following: the visual inspection of the returned twist drill shows deformations of the flutes which indicate that the drill was stuck and got damaged during reverse cycle.The deformed flutes of the smaller part indicates that as well.Note that the shaft is also bent which lead us believe that far too much force had been applied during drilling.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
The tip of the drill breaks during operation of the skull distal osteosynthesis.The drill passed through the skin on the other side.

• Brand Name: TWIST DRILL, DIAM.2.0X102MM, WL 50MM, AO-SHAFT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8010757
• Report Number: 0008031020-2018-00905
• Device Sequence Number: 19269225
• Product Code: LXH
• UDI-Device Identifier: 04546540645791
• UDI-Public: 04546540645791
• 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): 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/23/2023
• Device Catalogue Number: 45-27010
• Device Lot Number: AH12/BB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Initial Date Received by Manufacturer: 09/28/2018
• Supplement Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 10/26/2018
• Supplement Report FDA Received Date: 12/28/2018
• 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