MAUDE Adverse Event Report: CONMED LARGO HALL; BATTERY, REPLACEMENT, RECHARGEABLE

Catalog Number	L3500SB
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer, that l3500sb, hall small bone lithium power unit was being used on (b)(6) 2024 during an unknown procedure when it was reported ¿the housing broke.¿.Further assessment questioning found that a piece fell off the unit into the surgical site and was removed with pickups.The procedure was completed and there was no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The evaluation found that the weld that binds the head to the body has failed.Based on the evaluation a likely cause of this issue is insufficient weld.Although this is a reusable device, it is not serviceable.Therefore, a service history is not available for review.A device history record (dhr) review found no abnormalities that would contribute to this reported event.A two-year review of complaint history revealed there has been a total of 44 complaints, regarding 47 devices, for this device family and failure mode.During this same time frame 4,797 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 0.01.Per the instructions for use, the user is advised to inspect power unit for damage (e.G., cracks in power unit case, corrosion on contacts, etc) prior to use.Do not use damaged power units.If power unit is damaged and leakage or residue is noticed, do not allow it to come in contact with skin, eyes or clothing.Burns may result.If contact occurs, flush area with copious amounts of water and seek medical attention immediately.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer, that l3500sb, hall small bone lithium power unit was being used on (b)(6) 2024 during an unknown procedure when it was reported ¿the housing broke.¿.Further assessment questioning found that a piece fell off the unit into the surgical site and was removed with pickups.The procedure was completed and there was no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: HALL
• Common Device Name: BATTERY, REPLACEMENT, RECHARGEABLE
• 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: 20639830
• Report Number: 1017294-2024-00127
• Device Sequence Number: 20705022
• Product Code: MOQ
• UDI-Device Identifier: 30653405005524
• UDI-Public: (01)30653405005524(11)240828
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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: L3500SB
• Device Lot Number: 20241816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic