MAUDE Adverse Event Report: CONMED CORPORATION 3.5MM STERLING SPHERICAL BUR; ARTHROSCOPIC SHAVER/BUR

Model Number	H9110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint is confirmed.The returned used device, item h9110, was inspected and found inner tube broken off at the tip.Broken blade tip was returned for the evaluation.Additionally, the outer tube was damaged at the tip.Discrepancies with returned product critical dimensions could not be found.This is a technique dependent device and the most likely cause of this suspected failure is user related.Excessive force, lateral/side loading, and/or stalling of the device could have contributed to breakage of inner tube.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution were found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.(b)(4).Per the instructions for use, the user is advised the following; do not apply excessive loading on the shaver blade or bur.Cutting performance is not increased with force.Excessive force or using shaver blades or burs as a lever can cause damage to the device including permanent deformation, shedding of metal (wear), motor seizure, and overheating.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The distributor reported on behalf of the customer that the h9110, 3.5mm sterling spherical bur, broke during use on (b)(6) 2019.The inner shaft of the product was broken.There was no user or patient injury or impact.There was no reported delay of surgery.The procedure was completed.This report is being raised based on a device malfunction with potential for injury upon reoccurrence.

• Brand Name: 3.5MM STERLING SPHERICAL BUR
• Common Device Name: ARTHROSCOPIC SHAVER/BUR
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 8734491
• Report Number: 1017294-2019-00068
• Device Sequence Number: 16787189
• Product Code: GFF
• UDI-Device Identifier: 10845854012802
• UDI-Public: (01)10845854012802(17)231025(10)969458
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/26/2019

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 Expiration Date: 10/25/2023
• Device Model Number: H9110
• Device Catalogue Number: H9110
• Device Lot Number: 969458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 06/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1