MAUDE Adverse Event Report: CONMED POWERPRO PRO7020 ATTACHMENT; SURGICAL DRILL ATTACHMENTS

Catalog Number PRO7020

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/15/2018

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.

Event Description

The conmed sales representative reported that during a procedure the (b)(4) "sheared off during use, the gearing ended up on the or floor." upon gathering additional information, it was reported part of the bur and attachment of the device was resting in the patient's hip, which were retrieved from the patient.The procedure was completed with no reported surgical delays.No patient injury was reported.This report is being raised on the basis of a reported malfunction with potential for injury with recurrence.

Manufacturer Narrative

The used device was returned to conmed for evaluation.Inspection of the device found that the attachment came apart due to insufficient loctite.The device serviced with loctite applied to all threads.The device met all specifications during final testing.Service history was reviewed and no prior data was found.The manufacture recommends for this device preventative maintenance every 12 months.A review of the manufacturing documents verified the device was produced per current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified at the time of manufacture.A two-year review of complaint history revealed 3 other similar complaints for this product family and failure mode.(b)(4).The instructions for use advises the user of the following.Always inspect for bent, dull or damaged accessories (i.E., burs, cutting wheels) before each use.Do not use if damaged.To reduce the risk of injury, prior to surgery spin the bur guard on a bur.If the bur guard spins freely, the bearing is good.Otherwise, do not use.The bur guard must be sent for repair immediately.Do not immerse the pro7020 attachment or bur guard.Heavy use of the handpiece exceeding the recommended duty cycle can cause the handpiece and/or attachment to overheat.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: POWERPRO PRO7020 ATTACHMENT
• Type of Device: SURGICAL DRILL ATTACHMENTS
• Manufacturer (Section D): CONMED; 11311 concept blvd.; largo FL 33773
• MDR Report Key: 7592559
• MDR Text Key: 111027339
• Report Number: 1017294-2018-00074
• 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: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PRO7020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 85 YR