MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG TWIST DRILL, DIAM.1.6X115MM, WL 35MM, STRYKER SHAFT END, MANDIBULAR FRACTURE AND; INSTRUMENT

Model Number	91-16035
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the drill bit partially fragmented.No other information is known at this time.
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.

• Brand Name: TWIST DRILL, DIAM.1.6X115MM, WL 35MM, STRYKER SHAFT END, MANDIBULAR FRACTURE AND
• Common Device Name: INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: rylee koole ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 76145120
• MDR Report Key: 15103916
• Report Number: 0008010177-2022-00025
• Device Sequence Number: 20147455
• Product Code: HBE
• UDI-Device Identifier: 04546540493736
• UDI-Public: 04546540493736
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K070876
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/26/2022

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
• Device Model Number: 91-16035
• Device Catalogue Number: 91-16035
• Device Lot Number: TBC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown