MAUDE Adverse Event Report: CONMED HALL; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	00507112900
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of the customer that the device 00507112900, large bone, hall blade, oscillating, 19.5 x 105 x 1.27 was being used and there was a ¿broken saw blade¿ there was no impact or injury to the patient or user.Per further assessment it was reported that the device fragments fell into the surgical site and were retrieved.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The reported device has been returned to conmed; however, the investigation of the device has not been completed.A supplemental and final report will be filed following the completion of the device and complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: HALL
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): CONMED; 525 french rd; utica NY 13502
• 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: 25280044
• Report Number: 1017294-2026-00119
• Device Sequence Number: 10094965
• Product Code: GFA
• UDI-Device Identifier: 10845854003770
• UDI-Public: (01)10845854003770(17)310222(10)1532767
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2026

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: 00507112900
• Device Lot Number: 1532767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 05/26/2026
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown