MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., TOMCAT SHAVER BLADE, F - SERIES - 5.5MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	0375565000
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that a piece of the shaver broke off inside the patient.All pieces were retrieved and the procedure was completed successfully.
Additional Manufacturer Narrative
Alleged failure: 5.5 shaver jammed/got nicked, tooth potentially broke off and surgeon removed and used a new one.The failure identified in the investigation is consistent with the complaint record.The probable root cause/s could be the tip came into contact with hard material during use or excessive force applied by the user.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.Lot number is unknown; therefore, manufacture date can not be confirmed.
Event or Problem Description
It was reported that a piece of the shaver broke off inside the patient.All pieces were retrieved and the procedure was completed successfully.
Additional Manufacturer Narrative
Alleged failure: 5.5 shaver jammed/got nicked, tooth potentially broke off and surgeon removed and used a new one.The failure identified in the investigation is consistent with the complaint record.The probable root cause/s could be the tip came into contact with hard material during use or excessive force applied by the user.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.Lot number is unknown; therefore, manufacture date can not be confirmed.
Event or Problem Description
It was reported that a piece of the shaver broke off inside the patient.All pieces were retrieved and the procedure was completed successfully.

• Brand Name: PKG., TOMCAT SHAVER BLADE, F - SERIES - 5.5MM
• 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: 7706371
• Report Number: 0002936485-2018-00542
• Device Sequence Number: 16420854
• Product Code: GFA
• UDI-Device Identifier: 37613327061933
• UDI-Public: 37613327061933
• 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): 10/03/2018

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: 0375565000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Initial Date Received by Manufacturer: 06/29/2018
• Supplement Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 07/20/2018
• Supplement Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1