MAUDE Adverse Event Report: CONMED CORPORATION 3MM ROUND BUR MEDIUM, CARBIDE; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	5091-226
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is unconfirmed, only that it was on or around (b)(6) 2021.At time of filing, the reported device is not expected to be returned to conmed for evaluation.This reported event is entering the investigation process.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
On behalf of the customer, the conmed representative reported issues with the conmed 3mm round bur medium, carbide, item # 00509122600 (5091-226) lot 1123936 that (b)(6) recently experienced.It was reported that during a procedure on or about (b)(6) 2021, the bur broke during use.It is indicated the tip of the bur could not be retrieved and it was left in the patient, however it is also noted there was no patient impact or injury.To date, although multiple attempts have been made to gather additional information, no information has been made available.This report is being raised on the basis of injury since the fragment is noted to have been left in the patient.
Additional Manufacturer Narrative
Investigation of the customer's complaint of breakage is confirmed.A visual examination of the returned used, item: 00509122600, found the bur tip detached from the shaft.Condition of the returned device bur shows evidence of misuse due to return shaft has been burned from excessive heat and force used during case.The detached bur head was not returned.The examination was based on and confirmed per bur, round, 8 flute, 3.0 mm, design prints and information.The manufacturing documents from the device history record have been reviewed and found no abnormalities that would contribute to this issue.A lot history review was conducted and found no other events for this lot number and failure mode.(b)(4).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.Also per the ifu the user is advised that it is the surgeon's responsibility to be familiar with the appropriate surgical techniques prior to use of the equipment and its associated accessories.Do not use equipment if, upon receipt, package is opened, damaged, or shows any signs of tampering.Continually check handpiece for overheating.If overheating is sensed, immediately discontinue use and return for equipment service.Overheating of the blade, bur or wire may cause damage to the blade, bur or wire and may cause burns or thermal necrosis.Always inspect for bent, dull or damaged blades or burs before each use.Do not attempt to straighten or sharpen.Do not use if damaged.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: 3MM ROUND BUR MEDIUM, CARBIDE
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd; largo FL 33773 4908
• MDR Report Key: 11562760
• Report Number: 1017294-2021-00136
• Device Sequence Number: 14577088
• Product Code: GFF
• UDI-Device Identifier: 10845854007358
• UDI-Public: (01)10845854007358(17)251018(30)1(10)1123936
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/18/2025
• Device Model Number: 5091-226
• Device Catalogue Number: 00509122600
• Device Lot Number: 1123936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 04/23/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other