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.

• Brand Name: POWERPRO PRO7020 ATTACHMENT
• Type of Device: SURGICAL DRILL ATTACHMENTS
• Manufacturer (Section D): CONMED; 11311 concept blvd.; largo FL 33773
• Manufacturer (Section G): CONMED; 11311 concept blvd.; largo FL 33773
• Manufacturer Contact: martha camacho urribarri ; 525 french road; utica, NY 13502 ; 3156243051
• 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
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/11/2018

1 Device Was Involved in the Event

0 PatientS WERE 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
• Is The Reporter A Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 07/09/2018
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 05/02/2017
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage