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	08/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The alleged h9133 (qty 2) devices were not returned and no photographic evidence was provided.Therefore, the reported failure cannot be verified.The complaint of broken device is unable to be verified and a root cause cannot be determined.A lot history review was conducted and found (b)(4) complaints with a quaintly of (b)(4) units for this lot number and failure mode.In 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) percent.A device history found no anomalies that would contribute to this issue.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.The issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that 2 "h9133 - 4.5mm sterling, lightning, blades came loose from where it engages in the hub.It comes apart before touching the bone".This was reported with no patient injury but a 30-minute surgical delay.Further attempts were made for additional information, no other information was made available.Based on the decision tree results and provided information, this will be reported as a device malfunction.

• 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: 7823462
• Report Number: 1017294-2018-00131
• Device Sequence Number: 1198004
• Product Code: GFF
• UDI-Device Identifier: 10845854029671
• UDI-Public: (01)10845854029671(17)230517(10)932460
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 08/28/2018

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: 05/17/2023
• Device Catalogue Number: H9133
• Device Lot Number: 932460
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1