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

Catalog Number	H9133
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned used device wa evaluated by the manufacturing and quality engineer.It was found the hubs had dimensional challenges and there is variation within the knurl.A review of the device history found no anomalies that would contribute to this issue.A two-year review of complaint history revealed there has been a total of (b)(4) complaints, regarding (b)(4) 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; direct contact of the rotating cutting edge of the 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.If contact does occur shaver blades or burs can break, seize, or shed metal particles.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 that 3 "h9133 - 4.5 mm 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 assessment revealed that the shaft was coming loose from the hub, so when the shaver was turned on the hub would spin but the shaver would not.There were no issues in placing the burs into the handpiece.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: BUR
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 7798979
• Report Number: 1017294-2018-00126
• Device Sequence Number: 18879951
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 08/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1