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

Model Number	H9133
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Examination of the returned used device, h9133, found bur detached from the inner hub, due to oversized inner hub dimension.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing inspection of the product.The product released were found to have met all specifications prior to shipment.A two-year complaint history shows there have been a total of (b)(4) complaints, regarding 53 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 for this reported failure, 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 our complaint system to assure patient safety.
Event or Problem Description
Customer reported that the sterling lightning bur, h9133, came apart at the hub during a shoulder sub-acromial decompression surgery.There was no patient injury or impact.There was no reported surgical delay.This will be reported as a device malfunction with potential for patient 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: 7923358
• Report Number: 1017294-2018-00145
• Device Sequence Number: 1806892
• Product Code: GFF
• UDI-Device Identifier: 20845854029678
• UDI-Public: (01)20845854029678(17)230308(10)913214
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/01/2018

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: 03/08/2023
• Device Model Number: H9133
• Device Catalogue Number: H9133
• Device Lot Number: 913214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 10/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1