MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 1.1MM WIRE PASS DRILL BIT MEDIUM; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	5300010059
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that during a surgical procedure , two drill bits broke.It was also reported that there was a five to ten minute delay as a result of this event to get a back-up device.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.This report is for the first drill bit that broke.
Additional Manufacturer Narrative
H6: the quality investigation is complete.
Event or Problem Description
It was reported that during a surgical procedure , two drill bits broke.It was also reported that there was a five to ten minute delay as a result of this event to get a back-up device.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.This report is for the first drill bit that broke.

• Brand Name: 1.1MM WIRE PASS DRILL BIT MEDIUM
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10414573
• Report Number: 0001811755-2020-02177
• Device Sequence Number: 16844856
• Product Code: GFF
• UDI-Device Identifier: 07613153000013
• UDI-Public: 07613153000013
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 09/22/2020

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 Expiration Date: 01/01/2025
• Device Model Number: 5300010059
• Device Catalogue Number: 5300010059
• Device Lot Number: 20009017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Initial Date Received by Manufacturer: 07/24/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 09/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1