MAUDE Adverse Event Report: CONMED LARGO HALL PRIMECUT CASSETTE 1.37 X 105 X 25 MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number SH137-105-25

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2021

Event Type  malfunction  

Event Description

The sales representative reported on behalf of the customer that the device, (b)(6),hall primecut cassette 1.37 x 105 x 25 mm was being used on 06dec21 during an unknown procedure and the blade broke during surgery - specifically several teeth from the right side of the blade.There was no impact or injury for the patient.Further assessment found that the fragments did fall into the surgical site.All 3 small fragments were retrieved with manual instruments and an x-ray was brought in to confirm that there were no more fragments remaining.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The reported device has been returned to conmed; however, the evaluation of the device has not been completed.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Manufacturer Narrative

The reported device has been returned to conmed; however, the evaluation of the device has not been completed.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the device, sh137-105-25, hall primecut cassette 1.37 x 105 x 25 mm was being used on (b)(6) 2021 during an unknown procedure and the blade broke during surgery - specifically several teeth from the right side of the blade.There was no impact or injury for the patient.Further assessment found that the fragments did fall into the surgical site.All 3 small fragments were retrieved with manual instruments and an x-ray was brought in to confirm that there were no more fragments remaining.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Event Description

The sales representative reported on behalf of the customer that the device, sh137-105-25, hall primecut cassette 1.37 x 105 x 25 mm was being used on 06dec21 during an unknown procedure and the blade broke during surgery - specifically several teeth from the right side of the blade.There was no impact or injury for the patient.Further assessment found that the fragments did fall into the surgical site.All 3 small fragments were retrieved with manual instruments and an x-ray was brought in to confirm that there were no more fragments remaining.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Customer event ¿blade broken during surgery - specifically several teeth from the right side of the blade¿ was confirmed based on photographic evidence and device evaluation.Evaluation of the returned used device, item sh137-105-25, found machined bur teeth broken, deformed.Returned product shows signs of misuse.Excessive force (load) was used during procedure.This is technique dependent device, and the most likely cause of this suspected failure is user related.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.A two-year lot history review was conducted and found 3 other similar events reported for this lot number involving 3 units; however, only 1 has been confirmed.A two-year review of complaint history revealed there has been a total of 11 complaints, regarding 11 devices, for this device family and failure mode.During this same time frame (b)(4) 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 0.002.Conmed encourages the inspection and/or test of all medical equipment prior to use to ensure all devices are functioning as expected.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: HALL PRIMECUT CASSETTE 1.37 X 105 X 25 MM
• Type of Device: 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 13117258
• MDR Text Key: 285226142
• Report Number: 1017294-2021-00378
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SH137-105-25
• Device Lot Number: 1191758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2021
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Treatment: X-RAY.; X-RAY.
• Patient Ethnicity: Non Hispanic