MAUDE Adverse Event Report: CONMED LARGO 1 X 19MM, WIRE PASS DRILL, MEDIUM, 5EA; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	5091-247
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The distributor reported on behalf of the customer that the device 00509124700, 1 x 19mm, wire pass drill, medium, 5ea, was used during a le fort i osteotomy on the date of (b)(6) 2022 when it was reported, ¿wire pass drill bit (medium) failing during procedure (small portion broke off on the field).¿.After further assessment, it was reported, "wire pass drill (medium) small portion broke off on field.Field searched, floor searched with magnet, x-ray taken.Object not found.".There was no report of a delay, patient or user impact, prolonged hospitalization or medical intervention for the patient.This report is being raised on the basis of injury due to possible fragmentation left in the body.
Additional Manufacturer Narrative
The reported device is not 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.
Event or Problem Description
The distributor reported on behalf of the customer that the device 00509124700, 1 x 19mm, wire pass drill, medium, 5ea, was used during a le fort i osteotomy on the date of (b)(6)2022 when it was reported, ¿wire pass drill bit (medium) failing during procedure (small portion broke off on the field).¿.After further assessment, it was reported, "wire pass drill (medium) small portion broke off on field.Field searched, floor searched with magnet, x-ray taken.Object not found.".There was no report of a delay, patient or user impact, prolonged hospitalization or medical intervention for the patient.This report is being raised on the basis of injury due to possible fragmentation left in the body.
Additional Manufacturer Narrative
The device will not be returned, and no photographic evidence was provided.Therefore, the reported event cannot be verified.A device history record review found no abnormalities that would contribute to this reported event.The product released for distribution was found to have met all specifications prior to shipment.A two-year lot history review shows this is the only complaint for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 14 reports, regarding 17 devices, for this device family and failure mode.During this same time frame 426,999 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 0.00004.Per the instructions for use, the user is advised the following: bur guards should always be checked before use.To reduce the risk of injury, prior to surgery, spin the bur guard on a bur.If the bur guard spins freely, the bearing is still good.Otherwise, the bur guard must be sent for repair immediately.Do not use.Overheating can occur if bur guard bearings are worn or not kept clean.Do not operate the drills without the appropriate bur guard and 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.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: 1 X 19MM, WIRE PASS DRILL, MEDIUM, 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: aubrey nardozzi ; 11311 concept blvd; largo, FL 33773 ; 7273995288
• MDR Report Key: 16395494
• Report Number: 1017294-2023-00006
• Device Sequence Number: 12356175
• Product Code: GFF
• UDI-Device Identifier: 10845854003169
• UDI-Public: (01)10845854003169(17)270425(30)1(10)1242551
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2023

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: 5091-247
• Device Catalogue Number: 00509124700
• Device Lot Number: 1242551
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2023
• Supplement Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: X-RAY; X-RAY
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic