MAUDE Adverse Event Report: STRYKER GMBH TWIST DRILL, DIAM.1.9X94MM, WL 27MM, STRYKER SHAFT END; BIT, DRILL

Model Number	60-19126
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2019
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) about the poor quality of product supplied by stryker under the captioned nps agreement.It was reported that ¿1.9mm drill bit broken during drilling of medial cuneiform.Drill bit fragment removed from patient completely, intraop c-arm showed no radioopaque remains or debris in bone¿.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the front part of the returned drill bit is indeed completely broken off.Damages on the cutting flutes are clearly visible.Also some discoloration as well as bone residues are evident.No further details were made available in order to understand the reported problem.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 possibly to much applied force.If any further information is provided, the investigation report will be updated.
Event or Problem Description
A report was received from cmc about the poor quality of product supplied by stryker under the captioned nps agreement.It was reported that ¿1.9mm drill bit broken during drilling of medial cuneiform.Drill bit fragment removed from patient completely, intraop c-arm showed no radioopaque remains or debris in bone¿.

• Brand Name: TWIST DRILL, DIAM.1.9X94MM, WL 27MM, STRYKER SHAFT END
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9420735
• Report Number: 0008031020-2019-02039
• Device Sequence Number: 1671345
• Product Code: HTW
• UDI-Device Identifier: 04546540247063
• UDI-Public: 04546540247063
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 60-19126
• Device Catalogue Number: 60-19126
• Device Lot Number: AE09/EA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1