MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., ANGLED AGG. PLUS SHAVER BLADE F - SERIES - 4.0MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	0380544100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2020
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 the device broke during the procedure.The piece was retrieved.
Additional Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.The reported failure mode will be monitored for future reoccurrence.Alleged failure: break.Probable root cause: instructions for use: manufacturing controls: qc incoming and in-process inspections (i.E.Window profile): design: window optimization; design: cutting edge/angle optimization; design: cutter/housing gap optimization; design: surface treatments, coatings, bearings; design: diamond grit size and coating optimization h3 other text : 81.
Event or Problem Description
It was reported the device broke during the procedure.The piece was retrieved.

• Brand Name: PKG., ANGLED AGG. PLUS SHAVER BLADE 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: 9687743
• Report Number: 0002936485-2020-00055
• Device Sequence Number: 3002325
• Product Code: GFA
• UDI-Device Identifier: 37613327054997
• UDI-Public: 37613327054997
• Combination Product (Y/N): N
• 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): 03/20/2020

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 Catalogue Number: 0380544100
• Device Lot Number: 19211CE2
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/30/2020
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1