MAUDE Adverse Event Report: STRYKER GMBH STANDARD DRILL BIT ANCHORAGE Ø2.0MM / L110MM, AO; SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENTS

Catalog Number	XFO082001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/20/2018
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
Primary left lapidus bunionectomy.It was reported that two 2.0 drill bits broke when they hit previously implanted screws.During bone fenestration, a 1.4 drill bit broke in patient's bone (no contact with any devices).Patient's bone quality was normal.A surgical delay of less than 10 minutes was caused due to the need to remove the broken portion of the bits, procedure was otherwise completed successfully.
Additional Manufacturer Narrative
The reported event that standard drill bit anchorage ø2.0mm / l110mm was alleged of ¿breakage during surgery¿ could be confirmed, since the device was returned for evaluation and matches the reported failure mode.Based on investigation, the root cause was attributed to be user related.The failure was caused by a misuse of the device.The breakage reported can be confirmed.The tip of the device is broken.The device inspection showed that the device is in a good condition, with no signs of extensive reprocessing.No marks of rust or color fading was noticed.The microscope images show a shiny fracture surface, a sign that the two broken parts of the device rubbed against each other.This observation proves that the fracture is due to the fatigue of the material.Most likely, an excessive cyclic loading was applied to the device leading to a final fatigue fracture.Furthermore, the drill should be used alongside drill guides to avoid any flexion combined to a torque, which can lead to the device breakage.Based on the above-mentioned observations the case could be classified as user-related.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.
Event or Problem Description
Primary left lapidus bunionectomy.It was reported that two 2.0 drill bits broke when they hit previously implanted screws.During bone fenestration, a 1.4 drill bit broke in patient's bone (no contact with any devices).Patient's bone quality was normal.A surgical delay of less than 10 minutes was caused due to the need to remove the broken portion of the bits, procedure was otherwise completed successfully.

• Brand Name: STANDARD DRILL BIT ANCHORAGE Ø2.0MM / L110MM, AO
• Common Device Name: SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENTS
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8257055
• Report Number: 0008031020-2019-00039
• Device Sequence Number: 16634069
• Product Code: HWE
• UDI-Device Identifier: 07613252265511
• UDI-Public: 07613252265511
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2019

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 Catalogue Number: XFO082001
• Device Lot Number: 11639Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 01/17/2019
• Supplement Report FDA Received Date: 03/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR