MAUDE Adverse Event Report: CONMED CORPORATION MICROFREE RECIPROCATING SAW; SAW, POWERED, AND ACCESSORIES

Catalog Number PRO8400SB

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2020

Event Type  malfunction  

Manufacturer Narrative

At time of filing, although expected, the reported device has not been 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

On behalf of the customer, the conmed representative reported issues involving the pro8400sb, microfree reciprocating saw sn# (b)(4) that occurred at (b)(6), on (b)(6) 2020.Information received was the saw blade kept falling out of the collet while in use in a patient.Clarification was received that indicates during a left total ankle replacement the reciprocating saw blade fell out of the collet on the saw twice.Prior to using the saw, the blade was appropriately seated and placed in collet.The collet was hand tightened.The blade fell out following approximately 5 seconds of use on patient.The surgeon removed the blade from the patient's ankle and reattached the blade to the handpiece.After the blade fell out the second time, the blade was removed by hand, fully intact, and the handpiece was set aside.The surgeon completed the necessary cut using a large bone sagittal saw and the procedure was successfully completed with no further issue.There was no impact or injury to the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence as the blade fell into the patient but was removed.

Manufacturer Narrative

Despite multiple attempts to obtain the device for return to conmed for evaluation, the device has not been located or returned to conmed by the facility.Its location is unknown.No photographic evidence has been provided.Therefore, the reported failure cannot be verified, nor a root cause determined.Should the device in question be returned, an evaluation will be performed and a supplemental and final report will be filed.The manufacturing documents from the device history record have been reviewed and found no abnormalities that would contribute to this issue.The service history was reviewed, and no data was found.At the time of the complaint, the device was 8 months of age.A two-year review of complaint history revealed there has been a total of 3 complaints, regarding 3 devices, for this device family and failure mode.During this same time frame(b)(4) have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, (b)(4).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.The ifu advises the user to perform the required preoperative and functional tests for the equipment and accessories prior to each use.The ifu also advises the user to ensure all accessories are correctly and completely attached to the hand piece prior to use.Additionally, the ifu also advise the user to ensure hall small bone lithium power unit is in the "safe" mode prior to installing or removing the blade from the reciprocating saw.To insert a blade: 1.Twist the blade locking collar counter-clockwise and insert the shank of the blade or rasp into the collet.Ensure the blade or rasp is fully seated.2.Twist the blade lock collar clockwise and tighten securely.Round shank blades or rasps can be seated at any position within a 360 degree range however, flat blades must be aligned with the slot in the collet.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: MICROFREE RECIPROCATING SAW
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd; largo, fl
• MDR Report Key: 10411053
• MDR Text Key: 205688593
• Report Number: 1017294-2020-00354
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PRO8400SB
• Device Lot Number: 20190492
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 08/14/2020
• Supplement Dates Manufacturer Received: 09/29/2020
• Supplement Dates FDA Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1