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

Catalog Number	0375940012
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/08/2018
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 device broke during procedure.All pieces were removed successfully.
Additional Manufacturer Narrative
Alleged failure: break probable root cause: inadequate window profile.Inadequate welding process (i.E.Plasma, inductive, gluing).Improper material strength.Inadequate size selected for the application.Material brittleness.Excessive force applied by the user.Incorrect rfid tag.The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the device broke during procedure.All pieces were removed successfully.

• Brand Name: PKG., ROUND 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: 8030867
• Report Number: 0002936485-2018-00672
• Device Sequence Number: 1525573
• Product Code: GFA
• UDI-Device Identifier: 37613327054720
• UDI-Public: 37613327054720
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2019

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: 0375940012
• Device Lot Number: 18117CE2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 11/01/2018
• Supplement Report FDA Received Date: 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 112