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

Model Number	PRO9300B
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The distributor reported on behalf of the customer that the pro9300b, hall titan oscillating saw battery handpiece, was being used during a tka procedure on the date of (b)(6) 2023 when it was reported, ¿the oscillator head of the main body was cut off during osteotomy using this hall titan oscillator.¿.After further assessment, it was reported the device did fragment in the surgical site.The fragment was retrieved with a ¿forcep like¿ instrument.The patients status is reported to be in good standing.The procedure was completed with a back up instrument and no report of medical intervention, or prolonged hospitalization for the patient.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.Device not yet received.
Additional Manufacturer Narrative
Reported event of ¿oscillator head of the main body was, "cut off¿ was confirmed based on photographic evidence and device evaluation.Additional problems were found.The pm was overdue.The unit is not repairable.Damaged found to the housing.The motor bearings are rough.The lubrication is no longer effective.The seal is worn.The controller failed.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 previous service data was found.A two-year review of complaint history revealed there has been a total of 26 reports, regarding 28 devices, for this device family and failure mode.During this same time frame 9,441 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 0.003.Per the instructions for use, the user is advised the following: regular and proper maintenance of your equipment is the best way to protect your investment.It is essential that you have your equipment serviced as scheduled in order to retain its optimum performance and reliability, which will reward you with safer, less problematic product performance over time.The hall® titan¿ handpieces shall be returned every 12 months for servicing.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 pro9300b, hall titan oscillating saw battery handpiece, was being used during a tka procedure on the date of (b)(6) 2023 when it was reported, ¿the oscillator head of the main body was cut off during osteotomy using this hall titan oscillator.¿.After further assessment, it was reported the device did fragment in the surgical site.The fragment was retrieved with a ¿forcep like¿ instrument.The patients status is reported to be in good standing.The procedure was completed with a back up instrument and no report of medical intervention, or prolonged hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: HALL TITAN 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: aubrey nardozzi ; 11311 concept blvd; largo, FL 33773 ; 7273995288
• MDR Report Key: 16324754
• Report Number: 1017294-2023-00009
• Device Sequence Number: 7993036
• Product Code: HAB
• UDI-Device Identifier: 40845854050799
• UDI-Public: (01)40845854050799(11)210616
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2023

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: PRO9300B
• Device Catalogue Number: PRO9300B
• 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: 01/17/2023
• Supplement Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2021
• 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