MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG DRILL FOR 8MM, 1.5X50MM, STRYKER-SHAFT; INSTRUMENT

Catalog Number	60-15008
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the drill broke off into the patient bone.The broken piece remains in patient bone.No further information is available.
Additional Manufacturer Narrative
The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
Additional Manufacturer Narrative
The reported event of a drill breakage could be confirmed.Based on the investigation the root cause of the drill breakage was attributed to a user related issue due to applying too high forces during application in combination with collision and friction to another hard object.
Event or Problem Description
It was reported that during the procedure, the drill broke off into the patient bone.The broken piece remains in patient bone.No further information is available.

• Brand Name: DRILL FOR 8MM, 1.5X50MM, 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: 18136316
• Report Number: 0008010177-2023-00071
• Device Sequence Number: 6559929
• Product Code: HBE
• UDI-Device Identifier: 07613154184002
• UDI-Public: 07613154184002
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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: Distributor
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 60-15008
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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