MAUDE Adverse Event Report: CONMED LARGO 1/4 INCH 6.5MM POWERPRO 1/4 INCH CHUCK ATTACHMENT; SAW, POWERED, AND ACCESSORIES

Catalog Number	PRO2041
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The distributor reported on behalf of their customer that the device, pro2041, 1/4 inch 6.5mm powerpro 1/4 inch chuck attachment, was being used during an unknown procedure on (b)(6) 2024 when it was reported, ¿it was reported that this product broke into two pieces during use.¿ the procedure was completed using a backup instrument.There was no report of injury, medical intervention, or hospitalization for the patient.Further assessment questions found that the device was broken during surgery, fell into the patient and was retrieved using forceps.This report is being raised due to the reported 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.We will continue to monitor for trends through the complaint system to assure patient safety.
Additional Manufacturer Narrative
The unit came in two pieces with missing parts and the retaining ring was not seated properly.Preventative maintenance is not overdue.Preventative maintenance completed on this repair order.Repair/evaluation completed.Final test completed and met all specifications.Root cause cannot be determined, however, based upon evaluation of the device; a possible cause of this event could be that the retaining ring was not seated properly.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.The service history was reviewed, and no prior data was found.(b)(4).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 their customer that the device, pro2041, 1/4 inch 6.5mm powerpro 1/4 inch chuck attachment, was being used during an unknown procedure on (b)(6) 2024 when it was reported, ¿it was reported that this product broke into two pieces during use.¿ the procedure was completed using a backup instrument.There was no report of injury, medical intervention, or hospitalization for the patient.Further assessment questions found that the device was broken during surgery, fell into the patient and was retrieved using forceps.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: 1/4 INCH 6.5MM POWERPRO 1/4 INCH CHUCK ATTACHMENT
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 19403632
• Report Number: 1017294-2024-00062
• Device Sequence Number: 17839227
• Product Code: HAB
• UDI-Device Identifier: 10845854013052
• UDI-Public: (01)10845854013052(11)230530
• 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,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2024

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 Catalogue Number: PRO2041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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