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

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/21/2018

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event 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.

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 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
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 7991487
• MDR Text Key: 124673731
• Report Number: 0002936485-2018-00655
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 37613327061940
• UDI-Public: 37613327061940
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1