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
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It has been reported by the customer that during the use of the drill, the tip opens and can not be used.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 0008031020-2019-00751
• Device Sequence Number: 1669055
• Product Code: HWE
• UDI-Device Identifier: 07613252265481
• UDI-Public: 07613252265481
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2019

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 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
• Initial Date Received by Manufacturer: 06/07/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 08/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1