MAUDE Adverse Event Report: CONMED CORPORATION PRESSFT FLEX CURVED DRILL GUIDE; ACCESSORIES, ARTHROSCOPIC

Catalog Number CPGHC

Device Problems Device Damaged by Another Device (2915); Material Split, Cut or Torn (4008)

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

Event Date 01/29/2021

Event Type  malfunction  

Manufacturer Narrative

At time of filing, the reported device is not expected to be returned to conmed for evaluation.This reported event is entering the investigation process.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

On behalf of the customer, the conmed representative reported an issue with the cpghc, pressft flex curved drill guide, serial # (b)(4).It was noted that during a hip arthroscopy procedure on (b)(6) 2021, the pressft flex curved drill guide, was cutting into the internal components of the 8.5mm clear-trac smith and nephew cannula.This left plastic shards inside the joint each time the physician put the guide into the joint to drill for an anchor.Prior to the drill guide insertion, a shaver and straight bur were used with the cannula.It was indicated the procedures were successfully completed with a few minutes delay.There was no patient impact or harm as they did retrieve the shards that were scraped off.No other information was made available.This report is being raised on the basis of malfunction as the fragments (shards) were removed.

Manufacturer Narrative

Investigation of the customer's reported issue and complaint of the guide itself is likely too sharp was inconclusive.The device is not being returned and no photograph evidence was provided.Therefore, the reported failure could not be verified, root cause could not be identified.The manufacturing documents from the device history records (dhr) have been reviewed and found an ncr however it was not related to the manufacture of the device.Additionally, no abnormalities were found in the dhr that would contribute to this issue.A two-year lot history review found 2 events for this lot number and failure mode.(b)(4).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.The ifu also advises the to exercise care in the use of the device to minimize side or bending loads.Do not use excessive force on instruments to avoid damage or breakage during use.The ifu also advises the user to avoid unintended contact with other surgical instruments during use to prevent damage or breakage.Additionally, the ifu advises the user to inspect instrument after use to ensure it has not been damaged.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: PRESSFT FLEX CURVED DRILL GUIDE
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd; largo FL 33773 4908
• MDR Report Key: 11373487
• MDR Text Key: 242862996
• Report Number: 1017294-2021-00062
• Device Sequence Number: 1
• Product Code: NBH
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/12/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: CPGHC
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 03/08/2021
• Supplement Dates FDA Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8.5MM CLEAR-TRAC SMITH AND NEPHEW CANNULA; UNKNOWN SHAVER AND STRAIGHT BUR