MAUDE Adverse Event Report: CONMED LARGO 5MM ROUND BUR, LONG, CARBIDE, 5EA; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	5092-230
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.Not yet received the device.
Event or Problem Description
The distributor reported on behalf of the customer that the 00509223000, 5mm round bur, long, carbide, 5ea, was being used during an unknown procedure on the date of 07feb23, when it was reported, ¿our customer used this bur with the surgairtome two but did not use the bur guard.When used in that state, the spherical cut portion at the tip came off and remained in the bone.Also, the shaft broke in two.¿.After further assessment, it was reported the fragmentation still remains in the patient¿s bone.It is unknown if there was any delay or if another device was used.It was reported there was no patient or user impact, medical or surgical intervention.It is unknown if the patient required extended hospitalization.The patient is reported to be under observation.This report is being raised on the basis of injury due to fragmentation remaining in the patient¿s body.
Event or Problem Description
The distributor reported on behalf of the customer that the 00509223000, 5mm round bur, long, carbide, 5ea, was being used during an unknown procedure on the date on (b)(6) 2023, when it was reported, ¿our customer used this bur with the surgairtome two but did not use the bur guard.When used in that state, the spherical cut portion at the tip came off and remained in the bone.Also, the shaft broke in two.¿ after further assessment, it was reported the fragmentation still remains in the patient¿s bone.The procedure was completed with an alternate backup bur.It was reported there was no patient or user impact, medical or surgical intervention.It is unknown if the patient required extended hospitalization.The patient is reported to be under observation.This report is being raised on the basis of injury due to fragmentation remaining in the patient¿s body.
Additional Manufacturer Narrative
Correction to b.5: replaced, "it is unknown if there was any delay or if another device was used." to, " the procedure was completed with an alternate backup bur." correction to e.1: added "6-15 shinmachi kanagawa prf" to address.Reported event ¿spherical cut portion at the tip came off and remained in the bone¿ was inconclusive.The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 7 reports, regarding 7 devices, for this device family and failure mode.During this 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 operate the drills without the appropriate bur guard and the collet locked.Always use a bur of the proper length.The tip of the bur guard should cover the safe line on the bur, if applicable.Without the stabilization that the proper guard provides, the bur can break and be propelled with great force.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The distributor reported on behalf of the customer that the 00509223000, 5mm round bur, long, carbide, 5ea, was being used during an unknown procedure on the date of 07feb23, when it was reported, ¿our customer used this bur with the surgairtome two but did not use the bur guard.When used in that state, the spherical cut portion at the tip came off and remained in the bone.Also, the shaft broke in two.¿.After further assessment, it was reported the fragmentation still remains in the patient¿s bone.The procedure was completed with an alternate backup bur.It was reported there was no patient or user impact, medical or surgical intervention.It is unknown if the patient required extended hospitalization.The patient is reported to be under observation.This report is being raised on the basis of injury due to fragmentation remaining in the patient¿s body.
Additional Manufacturer Narrative
Update: the evaluation of the returned used device, item 00509223000 found the bur head detached from the shaft and the shaft was broken at the etch line as well.Critical dimensions were inspected and could not find any discrepancies with machined bur.No defects were found through measurement or examination of the returned product.Suspect, excessive force (load) was used during procedure.This is technique dependent device and the most likely cause of this suspected failure is user related.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 7 reports, regarding 7 devices, for this device family and failure mode.During this same time frame 447,014 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 0.00002.Per the instructions for use, the user is advised the following: do not operate the drills without the appropriate bur guard and the collet locked.Always use a bur of the proper length.The tip of the bur guard should cover the safe line on the bur, if applicable.Without the stabilization that the proper guard provides, the bur can break and be propelled with great force.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: 5MM ROUND BUR, LONG, CARBIDE, 5EA
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 16452640
• Report Number: 1017294-2023-00015
• Device Sequence Number: 17603346
• Product Code: GFF
• UDI-Device Identifier: 10845854001189
• UDI-Public: (01)10845854001189(17)270323(30)1(10)1236108
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2023

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 Model Number: 5092-230
• Device Catalogue Number: 00509223000
• Device Lot Number: 1236108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 03/24/2023; 07/10/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 04/17/2023; 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic