MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., BARREL BUR, 12 FLUTE F - SERIES - 4.0MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	0375941012
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the tips broke during the procedure.The pieces fell off outside of the patient and the procedure was completed successfully.
Additional Manufacturer Narrative
Per investigation results, the driveshaft broke off of all the returned units.The bur breaking at the hub would cause the bur to be unusable but will not cause harm to the patient.The procedure was completed successfully with no medical intervention or adverse consequences.There is no information to suggest that a recurrence would result in injury.Updated rationale from malfunction to no report required.
Event or Problem Description
It was reported that the tips broke during the procedure.The pieces fell off outside of the patient and the procedure was completed successfully.

• Brand Name: PKG., BARREL BUR, 12 FLUTE F - SERIES - 4.0MM
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 7733015
• Report Number: 0002936485-2018-00555
• Device Sequence Number: 2770688
• Product Code: GFA
• UDI-Device Identifier: 37613327054751
• UDI-Public: 37613327054751
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 10/03/2018

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: 0375941012
• Device Lot Number: 18026CE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1