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

Catalog Number	0375545000
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2020
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 that the inner tube tip of the device splitting during the procedure.All pieces were retrieved.
Event or Problem Description
It was reported that the inner tube tip of the device splitting during the procedure.All pieces were retrieved.
Additional Manufacturer Narrative
Alleged failure: the inner tube tip of the shaver split during routine meniscal resection.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be the blade comes in contact with a hard object causing damage to the teeth and hitting the housing edges.Excessive pressure, such as bending or prying, may cause the arthroscopic shaver blades to bend/break.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• Brand Name: PKG., TOMCAT 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: 10979884
• Report Number: 0002936485-2020-00510
• Device Sequence Number: 3699591
• Product Code: GFA
• UDI-Device Identifier: 37613327061797
• UDI-Public: 37613327061797
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2021

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: 0375545000
• Device Lot Number: 19170CE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Initial Date Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 02/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1