MAUDE Adverse Event Report: CONMED LARGO HALL TITAN PRIMECUT+ OSCILLATING SAW BATTERY HANDPIECE; SAW, POWERED, AND ACCESSORIES

Catalog Number PRO9350B

Device Problem Material Fragmentation (1261)

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

Event Date 08/10/2021

Event Type  malfunction  

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.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, pro9350b, was being used on approximately (b)(6) 2021 during an unknown cross procedure and the top piece of the saw came off.The doctor was able to retrieve the fragment with his hands.There was no report of patient impact or injury.Further assessment questions have been sent, but to date answers have not been received.This report is being raised on the basis injury of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Correction: b5 had an extra word that was taken out.Manufacturer narrative: reported event is inconclusive.To date, the device has not been returned for evaluation and no photographic evidence has been provided; therefore, the reported event 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.The service history was reviewed, and nothing was found.A two-year review of complaint history revealed there has been a total of 1 complaint, regarding 1 device, for this device family and failure mode.(b)(4).Per the instructions for use, the user is advised the following: do not apply excessive bending or twisting force to blade.Patient or user injury may occur.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, pro9350b, was being used on approximately (b)(6) 2021 during an unknown procedure and ¿the top piece of the saw came off.¿ the doctor was able to retrieve the fragment with his hands.There was no report of patient impact or injury.Further assessment questions have been sent, but to date answers have not been received.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: HALL TITAN PRIMECUT+ OSCILLATING SAW BATTERY HANDPIECE
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• MDR Report Key: 12383748
• MDR Text Key: 268723782
• Report Number: 1017294-2021-00327
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PRO9350B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1