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

Catalog Number	PRO7300B
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2023
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 distributor reported on behalf of their customer that the pro7300b, hall50 oscillating saw battery hpc was being used during a tka procedure on (b)(6) 2023 when it was reported ¿this handpiece snapped in two between the head and grip during osteotomy.¿.Further assessment questioning found that the fragment was retrieved with the use a ¿forcep-like instrument¿.The procedure was completed with the use of a backup power tool and there was no delay reported.There was no report of injury, medical intervention, or extended hospitalization for the patient or user.The current status of the patient was reported as ¿there have been no reports of adverse events¿.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The distributor reported on behalf of their customer that the pro7300b, hall50 oscillating saw battery hpc was being used during a tka procedure on (b)(6) 2023 when it was reported ¿this handpiece snapped in two between the head and grip during osteotomy.¿ further assessment questioning found that the fragment was retrieved with the use a ¿forcep-like instrument¿.The procedure was completed with the use of a backup power tool and there was no delay reported.There was no report of injury, medical intervention, or extended hospitalization for the patient or user.The current status of the patient was reported as ¿there have been no reports of adverse events¿.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
An evaluation of the returned device found that the housing broke where it meets the head, corrosion found inside.Needs new housing, motor and controller.The unit was repaired, evaluation completed and final tested.The unit met all specifications.Root cause cannot be determined, however, based upon evaluation of the device; a possible cause of this event could be not following service schedule for device.The preventive maintenance was overdue and completed as part of 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 previous service data was found.(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 this equipment and accessories.The hall 50 handpieces shall be returned every 12 months for servicing.We will continue to monitor for trends through the complaint system to assure patient safety.

• 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
• 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: 17349515
• Report Number: 1017294-2023-00067
• Device Sequence Number: 12272400
• Product Code: HAB
• UDI-Device Identifier: 10845854040041
• UDI-Public: (01)10845854040041(11)160310(30)1
• 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,Health Professional,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2023

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: PRO7300B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2023
• Supplement Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic