MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., XL ROUND DIAMOND BUR 4.0MM; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number	0485840000
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device overheated and melted the plastic on the device.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the device overheated and melted the plastic on the device.
Additional Manufacturer Narrative
Alleged failure: the blade to overheat and damage/melt the plastic on the shaver blade.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be excessive loading for an extended period of time without suction.It is also possible that a clog of the bur suction path hole would cause blockage of the fluid path, creating excessive heat buildup in the inner shaft and exposing the heat shrink to the heat enough which causing it to loosen.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• Brand Name: PKG., XL ROUND DIAMOND BUR 4.0MM
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• 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: 14215172
• Report Number: 0002936485-2022-00203
• Device Sequence Number: 5195251
• Product Code: GFF
• UDI-Device Identifier: 37613327301534
• UDI-Public: 37613327301534
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2022

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: 0485840000
• Device Lot Number: 21098CE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2022
• Supplement Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown