MAUDE Adverse Event Report: CONMED MICROPOWER OSCILLATOR SAW, DETACHABLE LEVER DRILL/SAW HANDPIECE, ELECTRIC

Catalog Number 00602002400

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/11/2017

Event Type  Injury  

Manufacturer Narrative

The reported device was returned to conmed for evaluation. The collet top was observed to be broken, the cast stator was blistering inside and rotor bearing was worn. This device should be serviced every 12 months; however, this device does not have a service history with conmed. A review of the manufacturing documents has verified the devices were produced per current and approved procedures and material specifications. Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture that would contribute to this issue. A two-year historical complaint review revealed no prior complaints related to this failure for this device. In that same timeframe, (b)(4) devices have been manufactured and shipped worldwide. A risk analysis was performed and this failure is deemed acceptable. The customer is advised of the following warning and precautions set forth in the instructions for use. -inspect all medical equipment before use. -preventative maintenance should be completed every 12-months. Service intervals are required to keep the equipment at its optimum operating performance. This incident type will continue to be monitored through the complaint system to assure patient safety.

Event Description

A biomedical hospital engineer reported while the doctor was using a micropower oscillator saw during a dental procedure, the head broke apart. It was reported pieces were left inside the patient, however, fragments were found inside the suction container and an x-ray did not confirm this claim. The procedure was completed with a 30-minute surgical delay and using an alternative device. The patient has recovered as expected. This report is raised on the basis of a reported device detachment that has the potential to adversely affect a patient. This report is classified as an injury due to fragments potentially being not retrieved.

• Brand Name: MICROPOWER OSCILLATOR SAW, DETACHABLE LEVER
• Type of Device: DRILL/SAW HANDPIECE, ELECTRIC
• Manufacturer (Section D): CONMED; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502
• Manufacturer Contact: lindsey sheppard ; 525 french road; utica, NY 13502 ; 7273995209
• MDR Report Key: 7167441
• MDR Text Key: 96472347
• Report Number: 1017294-2017-00150
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072706
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/05/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 00602002400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse