MAUDE Adverse Event Report: CONMED CORPORATION 4.5MM STERLING LIGHTNING; 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	08/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Examination of the device item, h9133, found the bur detached from the inner hub, due to oversized inner hub dimension.This is a manufacturing failure and is currently being investigated.A review of the device history review found no anomalies that would contribute to this issue.A two-year review of complaint history revealed there has been a total of 36 complaints, regarding 46 devices, for this device family and failure mode.During the same time frame (b)(4) devices were 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.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The customer reported the "h9133 - 4.5 mm sterling, lightning, "did not work properly and broke off".This was reported with no patient injury or surgical delay.Based on the decision tree results and provided information, this will be reported as a device malfunction with potential for injury upon reoccurrence.

• Brand Name: 4.5MM STERLING LIGHTNING
• Common Device Name: ARTHROSCOPIC SHAVER/BUR
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 7838737
• Report Number: 1017294-2018-00140
• Device Sequence Number: 1175719
• Product Code: GFF
• UDI-Device Identifier: 10845854029671
• UDI-Public: (01)10845854029671(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): 08/31/2018

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 Catalogue Number: H9133
• Device Lot Number: 913214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 08/31/2018
• Patient Sequence Number: 1