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

Device Problems Break (1069); Particulates (1451)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 02/21/2020

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event Description

It was reported that the device broke and potentially remains in the patient.

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 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
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9787452
• MDR Text Key: 182024963
• Report Number: 0002936485-2020-00117
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 37613327054751
• UDI-Public: 37613327054751
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other