MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., FULL RADIUS SHAVER BLADE, SMALL JOINT, F - SERIES - 2.5MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	0375627000
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/21/2018
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 base plastic component was burned by the heat of the friction at the bur shaft and there were no burns to the patient or users.
Additional Manufacturer Narrative
Alleged failure: a fire broke out at the proximal end of the shaver.It happened during use inside the joint, at 9000 rpm.The failure identified in the investigation is consistent with the complaint record.The probable root cause/s could be excessive force applied by the user with poor or no suction during use.The excessive force may cause friction due to the inner shaft assembly and housing assembly interaction.Another possibility the cutter was clogged or inadequate suction would prevent fluid being removed to provide cooling to the shaft.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the base plastic component was burned by the heat of the friction at the bur shaft and there were no burns to the patient or users.

• Brand Name: PKG., FULL RADIUS SHAVER BLADE, SMALL JOINT, F - SERIES - 2.5MM
• 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: 7991487
• Report Number: 0002936485-2018-00655
• Device Sequence Number: 13887895
• Product Code: GFA
• UDI-Device Identifier: 37613327061940
• UDI-Public: 37613327061940
• Combination Product (Y/N): N
• 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): 01/04/2019

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: 0375627000
• Device Lot Number: 18163CE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1