MAUDE Adverse Event Report: CONMED LARGO LARGE BONE HALL BLADE; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	5071-129
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the device, (b)(4), large bone hall blade was being used on 12jan22 during an unknown procedure and ¿while using hall power osc saw the large bone blade broke and cracked on second blade¿.There was no injury or impact to the patient.The procedure was completed with a different blade.There was a 15 minute delay to the procedure.Further assessment found that the device did fragment and all pieces were retrieved with a hemostat.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
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.
Event or Problem Description
The customer reported that the device, 00507112900, large bone hall blade was being used on (b)(6) 2022 during an unknown procedure and ¿while using hall power osc saw the large bone blade broke and cracked on second blade¿.There was no injury or impact to the patient.The procedure was completed with a different blade.There was a 15 minute delay to the procedure.Further assessment found that the device did fragment and all pieces were retrieved with a hemostat.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Reported event of blade breaking and fragmenting is confirmed based on device evaluation.Customer complaint of the large bone blade broke and cracked on second blade was confirmed.Visual examination of returned, used, item 00507112900, qty of two (2) found that the blades broken at the center of the teeth.Broke piece for one of the blades was not returned for the evaluation.Examination could not find any discrepancies with blade tooth profile.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.(b)(4).Conmed encourages the inspection and/or test of all medical equipment prior to use to ensure all devices are functioning as expected.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: LARGE BONE HALL BLADE
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• 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: 13506270
• Report Number: 1017294-2022-00022
• Device Sequence Number: 14463047
• Product Code: GFA
• UDI-Device Identifier: 10845854003770
• UDI-Public: (01)10845854003770(17)260906(30)1(10)1191976
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2022

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: 09/06/2026
• Device Model Number: 5071-129
• Device Catalogue Number: 00507112900
• Device Lot Number: 1191976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2022
• Supplement Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic