MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG DRILL F. 20MM SCREWS 1.6X58MM, STRYKER SHAFT; INSTRUMENT

Catalog Number	60-16526
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.
Event or Problem Description
It was reported that during the surgery, the drill bit being used broke off into the patients mandible.The broken bit was not retrievable and remains in the patient.
Event or Problem Description
It was reported that during the surgery, the drill bit being used broke off into the patients mandible.The broken bit was not retrievable and remains in the patient.
Additional Manufacturer Narrative
The reported event that a drill broke could not be confirmed because the drill was not available for investigation.Because the drill respectively the fragment was not returned a metallurgical examination of the fractured drill cannot be performed and it is also not possible to determine the precise root cause.Considering the description of the reported event that the angle of the drilling was not optimal it points to the fact that a user related issue has occurred.H3 other text : not available.

• Brand Name: DRILL F. 20MM SCREWS 1.6X58MM, STRYKER SHAFT
• 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 ; 7614888208
• MDR Report Key: 17995420
• Report Number: 0008010177-2023-00065
• Device Sequence Number: 12233431
• Product Code: HBE
• UDI-Device Identifier: 04546540731876
• UDI-Public: 04546540731876
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 01/17/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 60-16526
• Device Lot Number: AN07-BB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2023
• Supplement Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 01/17/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown