MAUDE Adverse Event Report: CONMED CORPORATION POWERPRO 5:1 ZIMMER/HUDSON REAMER ATTACHMENT

Catalog Number PRO6047

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/23/2019

Event Type  Injury  

Manufacturer Narrative

The report 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 customer reported that the pro6047, powerpro zimmer/hudson reamer attachment's stopped and fell apart.The o-rings failed and some of the bearings fell out into the op site during a total hip replacement surgery on (b)(6) 2019.Additional information was received that confirmed the bearings fell into the surgical site.They were removed using suction and graspers.It is not known if all of the bearings were removed.There was a surgical delay of 30-minutes reported.According to the customer post-operatively the patient seems okay, but the injury did require the patient to be admitted.This report is being raised as a patient injury due to the potential for retained device fragments.

Manufacturer Narrative

Evaluation of the returned used device per service and repair procedure spm31201340 rev af confirms the reported problem.Examination found input shaft bearing broken (damaged) and the bearing shields are no longer attached.Additionally, the returned device shows heavy signs of misuse and corrosion.The service history was reviewed, and no data was found.At the time of the complaint, the device was 84 months of age.(b)(4).Per the instructions for use, the user is advised the following; inspect all equipment for proper operation and ensure all attachments and accessories are correctly and completely attached to the hand piece.Do not immerse attachments or accessories.Conmed linvatec recommends that all powerpro attachments be returned for preventive maintenance every 24 months.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: POWERPRO 5:1 ZIMMER/HUDSON REAMER ATTACHMENT
• Type of Device: REAMER ATTACHMENT
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 9009111
• MDR Text Key: 161794132
• Report Number: 1017294-2019-00119
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PRO6047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Date Manufacturer Received: 09/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other