MAUDE Adverse Event Report: CONMED LARGO POWERPRO SAGITTAL SAW ATTACHMENT; SAW, POWERED, AND ACCESSORIES

Catalog Number PRO2043

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

A sales representative reported on behalf of a customer that the device, pro2043, powerpro sagittal saw attachment, was being used during a laterjet procedure on 01nov23 and "the powerpro sagittal saw attachment was being used with a 90 degree saw blade.When applying force the cut, the blade came loose and shot out of the hub nearly hitting a staff member¿.The procedure was completed using a pro8250sb, and there was a delay of ten minutes.There was no report of injury to the patient or user.A good faith effort was made to obtain additional information; no response was received.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

Event Description

A sales representative reported on behalf of a customer that the device, pro2043, powerpro sagittal saw attachment, was being used during a laterjet procedure on (b)(6) 2023 and "the powerpro sagittal saw attachment was being used with a 90 degree saw blade.When applying force the cut, the blade came loose and shot out of the hub nearly hitting a staff member¿.The procedure was completed using a pro8250sb, and there was a delay of ten minutes.There was no report of injury to the patient or user.A good faith effort was made to obtain additional information; no response was received.Update: per information received on 29nov23, the blade was fully locked in place at the time of the event, and there was no fragmentation.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The device will not be returned and no photographic evidence has been provided therefore the reported event cannot be verified.The service history was reviewed, and no data was found.A device history record review found no abnormalities that would contribute to the reported event.A two-year review of complaint history revealed there has been a total of 11 reports, regarding 11 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised: prior to each use, inspect all equipment for proper operation and ensure all attachments and accessories are correctly and completely attached to the handpiece.Handle all equipment carefully.If an attachment is dropped or damaged in any way, return it immediately for service.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: POWERPRO SAGITTAL SAW ATTACHMENT
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 18226804
• MDR Text Key: 329238976
• Report Number: 1017294-2023-00110
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PRO2043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 90 DEGREE SAW BLADE.; 90 DEGREE SAW BLADE.; PRO8250SB MICROFREE SAGITTAL.; PRO8250SB MICROFREE SAGITTAL.
• Patient Ethnicity: Non Hispanic