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

Model Number 60-19126

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/24/2019

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event 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¿.

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 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
• Type of Device: BIT, DRILL
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9420735
• MDR Text Key: 193327383
• Report Number: 0008031020-2019-02039
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 04546540247063
• UDI-Public: 04546540247063
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: 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 Manufacturer Received: 11/11/2019
• Initial Date FDA Received: 12/05/2019
• Supplement Dates Manufacturer Received: 01/16/2020
• Supplement Dates FDA Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1