MAUDE Adverse Event Report: STRYKER GMBH CALIBRATED DRILL BIT Ø2.5MM X 285MM, AO; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	703586
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/21/2019
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 was reported that the calibrated drill bit broke during the operation.The tip of this drill is trapped in the patient and it is unable to be taken out.Surgical delay due to 30 attempts to it take out.No adverse consequences reported.Procedure was completed successfully.
Event or Problem Description
It was reported that the calibrated drill bit broke during the operation.The tip of this drill is trapped in the patient and it is unable to be taken out.Surgical delay due to 30 attempts to it take out.No adverse consequences reported.Procedure was completed successfully.
Additional Manufacturer Narrative
The reported event could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by too much applied force (hard bone structure) or possible inadequate angulation during drilling.The device inspection revealed the following: the tip of the returned drill bit is completely broken off, the broken surface is homogenous.These characteristics indicate that far too much mechanical force had been used during drilling, which resulted in the breakage of the tip (overload beyond its calculated capability).Note that it was mentioned that the patient had hard bone, which explains the applied mechanical force.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.

• Brand Name: CALIBRATED DRILL BIT Ø2.5MM X 285MM, 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: 8804780
• Report Number: 0008031020-2019-00902
• Device Sequence Number: 327380
• Product Code: HWE
• UDI-Device Identifier: 04546540694089
• UDI-Public: 04546540694089
• 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): 09/23/2019

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: 703586
• Device Lot Number: KU60359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 09/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1