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

Catalog Number	45-27010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2019
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
A report was received from (b)(6); a sales rep was informed on (b)(6) 2019 that a variax 2 foot drill was broken during foot operation.The drill was broken so that the bit of the drill stayed for the patient.It took 5 minutes extra for the operation and to get the drill bit away from the patient and find a new drill.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the tip of the returned drill bit is completely broken off, just at the off last flute at the shaft.As the shaft of the drill bit appeared slightly deformed; it was decided to run a test using an ao drill, whereas the shaft was indeed turning slightly eccentric.This is usually a clear indication when the drill bit is used on an angle.Marks on the shaft indicate that too (damages from a drill guide).It should be noted that the remaining drill bit is in a poor condition.The broken surface indicates that high applied forces had been evident.Therefore, it has been determined that the root cause of the failure was caused due to too much mechanical force which was applied during drilling (as mentioned possible on an angle), which resulted in the tip breakage as indicated at the last flute (powerful dynamically overload during use).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.Based on investigation, the root cause was attributed to be user related.The failure was caused by too much applied mechanical force during drilling, possibly on to steep angle.If any further information is provided, the investigation report will be updated.
Event or Problem Description
A report was received from (b)(6) hospital; a sales rep was informed on 1.11.2019 that a variax 2 foot drill was broken during foot operation.The drill was broken so that the bit of the drill stayed for the patient.It took 5 minutes extra for the operation and to get the drill bit away from the patient and find a new drill.

• Brand Name: TWIST DRILL, DIAM.2.0X102MM, WL 50MM, AO-SHAFT
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9387545
• Report Number: 0008031020-2019-01988
• Device Sequence Number: 2242713
• Product Code: HTW
• UDI-Device Identifier: 04546540645791
• UDI-Public: 04546540645791
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2020

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: 45-27010
• Device Lot Number: AJ01/BB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Initial Date Received by Manufacturer: 11/01/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1