MAUDE Adverse Event Report: CONMED LARGO HALL 50¿; SAW, POWERED, AND ACCESSORIES

Catalog Number	PRO7200B
Medical Device Problem Code	Unintended Ejection (1234)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.
Event or Problem Description
A sales representative reported on behalf of a customer that the pro7200b, hall 50 dual trigger battery handpiece device was being used during a total hip procedure on an unknown date, and ¿an attachment (pro6045) came loose from the hand piece three times during the same surgery.The attachment came loose when it was put under pressure.According to the staff and surgeon, it was due to the handpiece and not the attachment.No harm came to the staff or patient¿.Follow-up assessment found that "the attachment came loose when it was used to cut of collum during a total hip surgery.The staff said that it happened when the saw was put under pressure during the cut.So the pro6045 was in the wound when it came off.It happened three times during this step of the surgery, but the surgeon was able to complete the cut and remove the collum.It came off in one piece.No components fell off from the pro6045 itself or the pro7200b." the procedure was completed without the use of an alternate device.There was no reported delay and no report of injury, medical/surgical intervention, or extended hospitalization for the patient.The pro6045, hall surgical powerpro reciprocating saw attachment will be listed as a concomitant device.There are no allegations filed against it.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Event or Problem Description
A sales representative reported on behalf of a customer that the pro7200b, hall 50 dual trigger battery handpiece device was being used during a total hip procedure on an unknown date, and ¿an attachment (pro6045) came loose from the hand piece three times during the same surgery.The attachment came loose when it was put under pressure.According to the staff and surgeon, it was due to the handpiece and not the attachment.No harm came to the staff or patient¿.Follow-up assessment found that "the attachment came loose when it was used to cut of collum during a total hip surgery.The staff said that it happened when the saw was put under pressure during the cut.So the pro6045 was in the wound when it came off.It happened three times during this step of the surgery, but the surgeon was able to complete the cut and remove the collum.It came off in one piece.No components fell off from the pro6045 itself or the pro7200b." the procedure was completed without the use of an alternate device.There was no reported delay and no report of injury, medical/surgical intervention, or extended hospitalization for the patient.The pro6045, hall surgical powerpro reciprocating saw attachment will be listed as a concomitant device.There are no allegations filed against it.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Evaluation of the device found controller failure and the outer ferrule was damaged/worn.Preventative maintenance is not overdue.Repair/evaluation completed.Final test completed and met all specifications.Root cause cannot be determined, however, based upon ifu; a possible cause of this event could be the device was not tested prior to use to ensure appropriate functionality with the attachment.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 one report, regarding one device, 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: it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of the equipment and its associated accessories.Handle all equipment carefully.If any equipment is dropped or damaged in any way, return it immediately for service.Prior to each use, perform the following: ensure all accessories are correctly and completely attached.Perform the required preoperative functional tests for the equipment and accessories.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: HALL 50¿
• 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 20075566
• Report Number: 1017294-2024-00099
• Device Sequence Number: 3200182
• Product Code: HAB
• UDI-Device Identifier: 10845854040034
• UDI-Public: (01)10845854040034(11)230705
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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: PRO7200B
• 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: 08/20/2024
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PRO6045, HALL SURGICAL POWERPRO SAW ATTACHMENT; PRO6045, HALL SURGICAL POWERPRO SAW ATTACHMENT
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic