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
Medical Device Problem Codes	Break (1069); Particulates (1451)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Date of Event	02/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the device broke and potentially remains in the patient.
Additional Manufacturer Narrative
Alleged failure: a piece of burr remained inside the patient (the side of the burr broke) the failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be the excessive force applied to the bur head, causing the flutes to rub on the housing surface.Also, a possibility of the bur tip accidentally encountered hard objects during use.Based on the amount of damage observed, it is likely that excessive pressure was maintained for a substantial amount of time and poor suction.The product was returned for investigation and the failure mode will be monitored for future re-occurrence.
Event or Problem Description
It was reported that the device broke and potentially remains in the patient.

• 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: 9787452
• Report Number: 0002936485-2020-00117
• Device Sequence Number: 618388
• Product Code: GFA
• UDI-Device Identifier: 37613327054751
• UDI-Public: 37613327054751
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0375941012
• Device Lot Number: 19226CE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2020
• Initial Date Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 06/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other