MAUDE Adverse Event Report: CONMED LARGO HALL TITAN PRIMECUT+ OSCILLATING SAW BATTERY HANDPIECE; SAW, POWERED, AND ACCESSORIES

Model Number	PRO9350B
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The distributor reported on behalf of the customer that the pro9350b, hall titan primecut+ oscillating saw battery handpiece device was being used during a total knee arthroplasty procedure on (b)(6) 2023 when it was reported ¿the oscillator head of the main body was cut off during osteotomy using this hall titan primecut+ oscillator." further assessment questioning found that the device did fragment and was retrieved using ¿instrument like forceps¿.The procedure was completed with an alternate "backup instrument" and there was no report of injury, medical intervention, or extended hospitalization for the patient.The current status of the patient was reported as ¿no problem¿.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.We will continue to monitor for trends through the complaint system to assure patient safety.Device not yet received.
Additional Manufacturer Narrative
Reported event ¿main body was cut off¿ was confirmed.An evaluation of the returned device found that the housing had damaged.The preventive maintenance was overdue and completed as part of this repair order.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.(b)(4).Per the instructions for use, the user is advised to always inspect handpiece and accessories prior to use.Do not use damaged equipment.Handle all equipment carefully.If any equipment is dropped or damaged in any way, return it immediately for service.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 the customer that the (b)(4), hall titan primecut+ oscillating saw battery handpiece device was being used during a total knee arthroplasty procedure on (b)(6) 2023 when it was reported ¿the oscillator head of the main body was cut off during osteotomy using this hall titan primecut+ oscillator." further assessment questioning found that the device did fragment and was retrieved using ¿instrument like forceps¿.The procedure was completed with an alternate "backup instrument" and there was no report of injury, medical intervention, or extended hospitalization for the patient.The current status of the patient was reported as ¿no problem¿.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: HALL TITAN PRIMECUT+ OSCILLATING SAW BATTERY HANDPIECE
• 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: 16577186
• Report Number: 1017294-2023-00020
• Device Sequence Number: 17317882
• Product Code: HAB
• UDI-Device Identifier: 40845854050805
• UDI-Public: (01)40845854050805(11)210622
• 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,User Facility,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2023

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 Model Number: PRO9350B
• Device Catalogue Number: PRO9350B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 03/20/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2021
• 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