MAUDE Adverse Event Report: CONMED CORPORATION 4.5MM STERLING LIGHTNING BUR; ARTHROSCOPIC SHAVER/BUR

Catalog Number	H9133
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint is confirmed.Examination found the bur detached from the inner hub due to oversized inner hub dimension and undersized outer diameter of the shaft.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.There have been 5 similar complaints involving 7 devices for this lot of product.A two-year review of complaint history revealed there has been 20 complaints regarding 30 devices for this device family and failure mode.During the same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following; do not use equipment if upon receipt, package is opened, damaged, or shows signs of tampering.Continually check for overheating, if overheating is sensed immediately discontinue use.Do not use burs for plunge cutting.Injury or damage could occur.Do not use shaver bur if they show any signs of damage.Inspect for bent, dull, or damaged blades and burs before each use.Do not apply excessive loading/force on the shaver blade or bur.Direct contact of the rotating cutting edge of shaver blades and burs with metallic surfaces and/or other hard surfaces such as arthroscopes, cannulas, or other instruments can cause damage to the devices, shaver blade or bur should be examined for damage and replaced if necessary.A determination for further investigation has been initiated.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The customer reported the h9133, sterling lightning shaver blade, broke during surgery.There were no issues inserting the shaver into the handpiece.There were no fragments that fell into the patient.There was no patient injury reported and a delay of 2-minutes for surgery.This report is being raised based on device malfunction with potential for injury upon reoccurrence.

• Brand Name: 4.5MM STERLING LIGHTNING BUR
• Common Device Name: ARTHROSCOPIC SHAVER/BUR
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 8411589
• Report Number: 1017294-2019-00030
• Device Sequence Number: 10867562
• Product Code: GFF
• UDI-Device Identifier: 10845854029671
• UDI-Public: (01)10845854029671(17)230626(10)942414
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/12/2019

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: 06/26/2023
• Device Catalogue Number: H9133
• Device Lot Number: 942414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 03/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1