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

Catalog Number	PRO7300B
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
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 per regulatory requirements to help ensure patient safety.H3 other text: device not yet received.
Event or Problem Description
The distributor reported on behalf of the customer that the device, pro7300b hall 50 oscillating saw battery handpiece was being used on (b)(6) 2025 during an osteotomy and "¿the oscillator head of the main body was cut off during osteotomy using this hall 50 oscillator.¿ per further assessment it was reported that "while cutting the distal femur, the tip broke off and some fine iron-like particles fell onto the bone.I heard that the wound was thoroughly cleansed.¿ there was no impact or injury to the patient or user.The procedure was completed with an alternate ¿backup instrument¿.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device will not be returned for evaluation, but photographic evidence has been provided and the handpiece was evaluated by the distributor and found corrosion on the fractured surface of the housing.A root cause cannot be determined; however, based upon evaluation of the device, a possible cause of this event could be that water had penetrated inside, weakening the housing and causing it to break due to vibrations during use.The service history was reviewed, and no data was found.A device history record (dhr) review found no abnormalities that would contribute to this reported event.(b)(4).Per the instructions for use, the user is advised the following: always place the handpiece in the ¿safe¿ position when not in use, and prior to repositioning the rotating head on the oscillating saw, rotating the collet on the reciprocating saw, or connecting or removing attachments and accessories.Ensure all accessories are correctly and completely attached.Do not stall handpieces, damage can occur.The hall 50 handpieces shall be returned every 12 months for servicing.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The distributor reported on behalf of the customer that the device, pro7300b hall 50 oscillating saw battery handpiece was being used on (b)(6) 2025 during an osteotomy and "¿the oscillator head of the main body was cut off during osteotomy using this hall 50 oscillator.¿ per further assessment it was reported that "while cutting the distal femur, the tip broke off and some fine iron-like particles fell onto the bone.I heard that the wound was thoroughly cleansed.¿ there was no impact or injury to the patient or user.The procedure was completed with an alternate ¿backup instrument¿.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 22553671
• Report Number: 1017294-2025-00089
• Device Sequence Number: 9439207
• 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,User Facility,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2016
• 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