MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG DRILL FOR 5MM, 1,35X50MM, STRYKER-SHAFT; INSTRUMENT

Model Number	60-13505
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the rotational plane of the burr was wobbly, a larger than normal hole was made.The surgeon ended up using a larger screw to complete the surgery.There was no clinically significant delay, no medical intervention, and no adverse consequences.
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.
Event or Problem Description
It was reported that during the procedure, the rotational plane of the burr was wobbly, a larger than normal hole was made.The surgeon ended up using a larger screw to complete the surgery.There was no clinically significant delay, no medical intervention, and no adverse consequences.
Additional Manufacturer Narrative
Updated: h6 the device was not returned for evaluation; therefore, a root cause could not be determined for the event.H3 other text : not available.

• Brand Name: DRILL FOR 5MM, 1,35X50MM, 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: 16716312
• Report Number: 0008010177-2023-00019
• Device Sequence Number: 17951296
• Product Code: HBE
• UDI-Device Identifier: 07613154183913
• UDI-Public: 07613154183913
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 06/29/2023

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: 60-13505
• Device Catalogue Number: 60-13505
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 06/29/2023
• 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
• Patient Sex: Unknown