MAUDE Adverse Event Report: STRYKER GMBH TWIST DRILL, DIAM.1.9X105MM, WL 41MM, AO-SHAFT; PLATE, FIXATION, BONE

Catalog Number	60-19340
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/01/2018
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
The pharmacist at the hospital reported to the sales rep the following event "during a complex fracture reduction at the distal end of the left radius, the end of a variax drill (diameter 1.9 mm) of our wrist variax box broke.Drill change.
Event or Problem Description
The pharmacist at the hospital reported to the sales rep the following event "during a complex fracture reduction at the distal end of the left radius, the end of a variax drill (diameter 1.9 mm) of our wrist variax box broke.Drill change.
Additional Manufacturer Narrative
The reported event that twist drill, diam.1.9x105mm, wl 41mm, ao-shaft was alleged of issue s-11 (breakage during surgery) could be confirmed, since the returned device matches with the alleged failure mode.Visual inspection of the product was performed, and the drill was found to be broken at the tip.The tip of the drill is twisted significantly with blunt/ dull cutting flutes.Even some parts of the green marking have come off.The presented damages are a result of a user error.The failure occurred due to application of too much forces while drilling.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.If any further information is provided, the complaint report will be updated.

• Brand Name: TWIST DRILL, DIAM.1.9X105MM, WL 41MM, AO-SHAFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7691485
• Report Number: 0008031020-2018-00502
• Device Sequence Number: 10989570
• Product Code: HRS
• UDI-Device Identifier: 07613153068495
• UDI-Public: 07613153068495
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K141430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2018

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: 60-19340
• Device Lot Number: AG06/BB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 12/01/2018
• 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