MAUDE Adverse Event Report: CONMED CORPORATION POWERPRO TRINKLE/AO ATTACHMENT; SAW, POWERED, AND ACCESSORIES

Catalog Number PRO2029

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

At time of filing, the reported device was returned to conmed for service repair.Upon review this reported event is reentering the investigation process.A supplemental and final report will be filed following the updated completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

This complaint was created from a notification from (b)(6) that the pro2029 was found to have a "4.5mm drill bit stuck on (device) attachment during surgery".Further assessment information has been requested; however, we have been advised that "we do not have other details and it is impossible for us to go back to ask the hospital again after so many months".The type of procedure and date of procedure is unknown.There was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed.This filing is being completed due to conmed (b)(6) filing to the hsa.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Reported event is confirmed.Customer event "4.5mm drill bit stuck on pro2029 attachment" was confirmed based on device evaluation.The drill bit was stuck as it seems to have been forced fit or the drill bit is misaligned from the grip of the ball bearing.Tried to push the pin out using a shaft, as the collet has been retracted, to disengage the drill bit.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and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 review of complaint history revealed there has been a total of two complaints, regarding two devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.(b)(4).Per the instructions for use, the user is advised the following: prior to each use, inspect all equipment for proper operation and ensure all attachments and accessories are correctly and completely attached to the handpiece.Always inspect for bent, dull or damaged burs, blades or drill bits before each use.Do not attempt to straighten or sharpen.After use, dispose of properly.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: POWERPRO TRINKLE/AO ATTACHMENT
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• MDR Report Key: 11148811
• MDR Text Key: 255905785
• Report Number: 1017294-2021-00005
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PRO2029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Date Manufacturer Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1