MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG DRILL FOR 8MM, 1,4X54MM, STRYKER, STERILE; INSTRUMENT

Model Number	91-14008
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the tip of the drill broke off into the patient and remains in patient.There is no significant surgery delay and no reported adverse events.
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.H3 other text : not available.
Event or Problem Description
It was reported that during the procedure, the tip of the drill broke off into the patient and remains in patient.There is no significant surgery delay and no reported adverse events.
Additional Manufacturer Narrative
Updated information: h4, h6.The reported event that a drill broke could not be confirmed because the drill was not available for investigation.Based on statistical evaluation, no indications were found for any product related issue.Product surveillance will continue to monitor complaints of this type for adverse trends.H3 other text : not available.

• Brand Name: DRILL FOR 8MM, 1,4X54MM, STRYKER, STERILE
• 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: 17325418
• Report Number: 0008010177-2023-00050
• Device Sequence Number: 20412890
• Product Code: HBE
• UDI-Device Identifier: 04546540493675
• UDI-Public: 04546540493675
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K070876
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 10/31/2023

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: 91-14008
• Device Catalogue Number: 91-14008
• Device Lot Number: 6000100452
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/04/2023
• Supplement Date Received by Manufacturer: 07/04/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2023
• 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