MAUDE Adverse Event Report: STRYKER GMBH CANNULATED DRILL BIT & COUNTERSINK FIXOS Ø1,7MM / L12MM, AO; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number XFO051201

Device Problems Fracture (1260); Defective Device (2588); Material Deformation (2976)

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

Event Date 06/07/2019

Event Type  malfunction  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

It has been reported by the customer that during the use of the drill, the tip opens and can not be used.

Manufacturer Narrative

The reported event could be confirmed.Visual inspection of the returned device revealed that the apex of the drill bit is broken into three pieces, which are bent away from the rotation axis.Based on investigation, the root cause was attributed to be user related.Most likely the k-wire was strongly bent while pulling out the rotating drill bit.The device history records have been reviewed carefully and no nonconformance was found.The drill bit was manufactured according to specifications.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 Description

It has been reported by the customer that during the use of the drill, the tip opens and can not be used.

• Brand Name: CANNULATED DRILL BIT & COUNTERSINK FIXOS Ø1,7MM / L12MM, AO
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8739914
• MDR Text Key: 149628447
• Report Number: 0008031020-2019-00751
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07613252265481
• UDI-Public: 07613252265481
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: XFO051201
• Device Lot Number: 12861Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Date Manufacturer Received: 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1