MAUDE Adverse Event Report: CONMED MICROCHOICE RECIPROCATING SAW

Catalog Number 00502002300

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 03/13/2018

Event Type  Injury  

Manufacturer Narrative

The used headpiece, without the reported blade, was returned to conmed for evaluation.Visual inspection and use testing with an alternate blade found that the blade cannot remain secure in the collet due to a broken saw mechanism.The saw mechanism remained attached to the microchoice handpiece.Manufacture recommendation for preventative maintenance for this device is every 12 months.A service history review found this device was overdue for maintenance with the last preventative maintenance performed on february 29, 2012.To date, although multiple attempts have been made, additional information regarding the patient and procedure has not been made available.A two-year review of complaint history revealed 9 other similar complaints for this product family and failure mode.A risk analysis was performed and found this failure mode and occurrence level to be consistent and acceptable with risk documents.The instructions for use advises the user of the following.Micropower handpieces and attachments shall be returned every 12 months for servicing.It is good medical practice to inspect and/or test equipment prior to use.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The conmed sales representative reported on behalf of the user facility that during a maxfax procedure, the 00502002300 reciprocating saw detached from the handpiece.This led to "a fair bit of trauma" to the patient.The facility did not have an alternate device, so the procedure was postponed to the next day.To date, no additional information regarding patient status or procedure has been made available.This report is being raised on the basis of a reported patient injury.

• Brand Name: MICROCHOICE RECIPROCATING SAW
• Type of Device: MICROCHOICE RECIPROCATING SAW
• Manufacturer (Section D): CONMED; 11311 concept blvd.; largo FL 33773
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502
• Manufacturer Contact: martha camacho urribarri ; 525 french road; utica, NY 13502 ; 3156243051
• MDR Report Key: 7426030
• MDR Text Key: 105311793
• Report Number: 1017294-2018-00048
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K072706
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00502002300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other