MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG TWIST DRILL, DIAM. 1.9X58MM, FOR 6+7MM SCREW LENGHT, STRYKER SHAFT END; INSTRUMENT

Model Number	92-19758
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
Event or Problem Description
It was reported by the company representative that during a, case, the drill bit broke when trying to drill into the skull.
Additional Manufacturer Narrative
The reported event that the drill broke off could be confirmed by helps of an image contained in the internal email correspondence in trackwise.Further, it was determined that the drill was broken off at the drill helix and the broken off drill fragment could be retrieved.Nevertheless, because the drill was not available for investigation (discarded after case) it is not possible to perform the product specific examinations and to determine the precise root cause for the broken off drill.No corrective and/or preventive action is deemed to be necessary at this moment.Product surveillance will continue to monitor complaints of this type for adverse trends and the complaint is added to the complaint trend.H3 other text: device discarded.
Event or Problem Description
It was reported by the company representative that during a, case, the drill bit broke when trying to drill into the skull.

• Brand Name: TWIST DRILL, DIAM. 1.9X58MM, FOR 6+7MM SCREW LENGHT, STRYKER SHAFT END
• Common Device Name: INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• MDR Report Key: 11237476
• Report Number: 0008010177-2021-00004
• Device Sequence Number: 4959736
• Product Code: HBE
• UDI-Device Identifier: 07613154629442
• UDI-Public: 07613154629442
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070876
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

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: 92-19758
• Device Catalogue Number: 92-19758
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 05/20/2021
• 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: Required Intervention