MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG DRILL FOR 8MM, 1,5X50MM, STRYKER, STERILE; INSTRUMENT

Model Number	91-15008
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the red colored ring on the drill bit was noted to be missing, posing the risk of a small component being lost in a surgical site.There was no clinically significant delay, no medical intervention, and no adverse consequences.
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 procedure, the red colored ring on the drill bit was noted to be missing, posing the risk of a small component being lost in a surgical site.There was no clinically significant delay, no medical intervention, and no adverse consequences.
Additional Manufacturer Narrative
Because the drill was discarded and no image for the drill could be provided the reported event cannot be confirmed.Summarizing all available information, the root cause of the reported event could not be determined.If additional information becomes available, the complaint will be reviewed.H3 other text : discarded.

• Brand Name: DRILL FOR 8MM, 1,5X50MM, 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: 16497684
• Report Number: 0008010177-2023-00012
• Device Sequence Number: 17702196
• Product Code: HBE
• UDI-Device Identifier: 04546540493682
• UDI-Public: 04546540493682
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 05/18/2023

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: 91-15008
• Device Catalogue Number: 91-15008
• Device Lot Number: 6000098170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2023
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2022
• 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