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

Catalog Number	SH127-090-25
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
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 per regulatory requirements to help ensure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, sh127-090-25, hall primecut cassette, 1.27 x 090 x 25 mm, was being used during a tkr procedure on (b)(6) 2024 when it was reported, ¿a tooth of the primecut saw blade broke off during the case, unable to find and this is the second time it has happened.Pt x-rayed post implantation of prothesis, no saw blade visible.Patient x-rayed to determine if fragment if saw blade was retained in the wound.X-ray confirmed that the saw blade tooth was not in the patient's surgical wound.".There was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed as planned.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, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.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.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 6 complaints, regarding 6 devices, for this device family and failure mode.During this same time frame 13,029 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 0.0005.Per the instructions for use, the user is advised not to use saw blades to pry, remove bone grafts, or as a leverage point.Do not apply excessive bending or twisting force to blade.Patient or user injury may occur.Avoid contact of blades with cutting blocks, retractors or other instrumentation.Damage to blade or instrumentation may occur.Metal fragments may cause injury to patient or user.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 the device, sh127-090-25, hall primecut cassette, 1.27 x 090 x 25 mm, was being used during a tkr procedure on 12nov24 when it was reported, ¿a tooth of the primecut saw blade broke off during the case, unable to find and this is the second time it has happened.Pt x-rayed post implantation of prothesis, no saw blade visible.Patient x-rayed to determine if fragment if saw blade was retained in the wound.X-ray confirmed that the saw blade tooth was not in the patient's surgical wound.".There was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed as planned.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: HALL PRIMECUT
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 20937609
• Report Number: 1017294-2024-00153
• Device Sequence Number: 4475934
• Product Code: GFA
• UDI-Device Identifier: 20845854083335
• UDI-Public: (01)20845854083335(17)271009(10)1273241
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

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: SH127-090-25
• Device Lot Number: 1273241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 12/16/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic