MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG TWIST DRILL FOR 6MM SCREWS, DIAM.1.35X50MM, WL 7MM, STRYKER-SHAFT, STERILE PACKE; INSTRUMENT

Model Number	91-13506
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the drill fractured during use.Procedure was successfully completed with a new drill bit.Patient received x rays to locate the fragments but nothing was found and will need a ct scan to check again.No other information is known at this time and no adverse consequences were reported.
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 FOR 6MM SCREWS, DIAM.1.35X50MM, WL 7MM, STRYKER-SHAFT, STERILE PACKE
• 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: amelia kesti ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 76145120
• MDR Report Key: 13192756
• Report Number: 0008010177-2022-00001
• Device Sequence Number: 19254003
• Product Code: HBE
• UDI-Device Identifier: 04546540493644
• UDI-Public: 04546540493644
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 91-13506
• Device Catalogue Number: 91-13506
• Device Lot Number: 1000421977
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown