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	09/19/2023
Type of Reportable Event	Malfunction
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.H3 other text : device not yet received.
Event or Problem Description
The customer reported that the device, pro2041, 1/4 inch 6.5mm powerpro 1/4 inch chuck attachment, was being used during an ex fix removal procedure on (b)(6) 2023 when it was reported ¿dr.Was removing an x fit and chucked up a steinman pin and the jacob¿s chuck completely fell apart.He did not put much torque and was able to remove it with his hand afterwards.¿.Further assessment questioning found that ¿there was no physical harm to the patient at all.The patient is doing well".The procedure was completed without the use of an alternate device.There was no report of injury, medical intervention, or extended hospitalization for the patient.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The customer reported that the device, pro2041, 1/4 inch 6.5mm powerpro 1/4 inch chuck attachment, was being used during an ex fix removal procedure on (b)(6) 2023 when it was reported ¿dr.Was removing an x fit and chucked up a steinman pin and the jacob¿s chuck completely fell apart.He did not put much torque and was able to remove it with his hand afterwards.¿.Further assessment questioning found that ¿there was no physical harm to the patient at all.The patient is doing well".The procedure was completed without the use of an alternate device.There was no report of injury, medical intervention, or extended hospitalization for the patient.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Evaluation of the device found the chuck was not pneumatically pressed to 1800 pounds.Preventative maintenance is not overdue.Repair/evaluation completed.Final test completed and met all specifications.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.A two-year review of complaint history revealed there has been a total of 2 complaints, regarding 2 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 that prior to each use, inspect all equipment for proper operation and ensure all attachments and accessories are correctly and completely attached to the hand piece.We will continue to monitor for trends through the complaint system to assure patient safety.

• 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 17911197
• Report Number: 1017294-2023-00095
• Device Sequence Number: 20707202
• Product Code: HAB
• UDI-Device Identifier: 10845854013052
• UDI-Public: (01)10845854013052(11)230530
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2023

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
• Device Lot Number: LAA41736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2023
• Supplement Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic