MAUDE Adverse Event Report: CONMED LARGO HALL50 OSCILLATING SAW BATTERY HPC; SAW, POWERED, AND ACCESSORIES

Catalog Number	PRO7300B
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation of the returned device found parts missing.The preventive maintenance was overdue and required.The preventive maintenance was performed as part of repair order.The unit was repair, evaluation completed and final tested.The unit 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 data was found.A two-year review of complaint history revealed there has been a total of 9 complaints, regarding 9 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, ensure all accessories are correctly and completely attached and perform the required preoperative functional tests for the equipment and accessories.The hall 50 handpieces shall be returned every 12 months for servicing.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, pro7300b, was being used during an unknown procedure on approximately the(b)(6) 2021 when it was reported safety switch fell off into patient, was retrieved.There was no report of injury, medical intervention, or hospitalization for the patient.Further information was requested through the sales representative; however, the representative has reported that the contact is not answering any calls.To date we have not received any further information from the facility.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: HALL50 OSCILLATING SAW BATTERY HPC
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• MDR Report Key: 12412917
• Report Number: 1017294-2021-00336
• Device Sequence Number: 19644670
• Product Code: HAB
• UDI-Device Identifier: 10845854040041
• UDI-Public: (01)10845854040041(11)181026
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/02/2021

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: PRO7300B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1