MAUDE Adverse Event Report: STRYKER GMBH CALIBRATED DRILL BIT 2.5MM X 285MM, AO; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	703586
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was retained by the hospital and will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
It was reported: the tip of the 2.5 drill bit broke off as it encountered another screw.The 2.5 perc drill bit (703586) broke in tibia while drilling.Several holes were drilled successfully in the tibia prior the event.Patient had decently hard bone.Procedure was completed successfully with replacement.Tips of drill bits were left in place as retrieval would have potentially caused damage to the bone.
Event or Problem Description
It was reported: the tip of the 2.5 drill bit broke off as it encountered another screw.The 2.5 perc drill bit (703586) broke in tibia while drilling.Several holes were drilled successfully in the tibia prior the event.Patient had decently hard bone.Procedure was completed successfully with replacement.Tips of drill bits were left in place as retrieval would have potentially caused damage to the bone.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.A device inspection was not possible since the affected device was not returned, and no other evidences were provided for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, based on past complaints and rmf some of the possible causes are but not limited to: too high torque, drill getting in contact with the implant (hard/metal object) due to misalignment, mistreatment of the instrument etc.If any additional information is provided, the investigation will be reassessed.

• Brand Name: CALIBRATED DRILL BIT 2.5MM 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 ; SZ 2545
• MDR Report Key: 11750920
• Report Number: 0008031020-2021-00201
• Device Sequence Number: 11796812
• Product Code: HWE
• UDI-Device Identifier: 04546540694089
• UDI-Public: 04546540694089
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 06/16/2021

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 Model Number: 703586
• Device Catalogue Number: 703586
• Device Lot Number: KU122989
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR