MAUDE Adverse Event Report: CONMED CORPORATION STAPLIZER HANDPIECE; TENDON/LIGAMENT STAPLER

Catalog Number T100

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2019

Event Type  malfunction  

Manufacturer Narrative

The reported device is expected to be 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 t100, staplizer would not properly load the staple cartridge and the staplizer was fired without a staple and cut the tendon during an acl/let (anterior cruciate ligament reconstruction/lateral extra-articular tenodesis) procedure on (b)(6) 2019.The staplizer was not pre-tested and none of the staple cartridges were able to be loaded properly.The doctor was able to use the cut tendon and used a crossft 4.75 suture anchor in place of the staple.The procedure was completed as expected and there was no patient injury.There was a 5-minute delay reported.This report is being raised on the basis of device malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Complaint is inconclusive.To date, the device has not been returned for evaluation and no photographic evidence has been provided.Therefore, the reported failure cannot be verified.The service history review could not be conducted due to the unavailability of a serial number.A dhr review could not be conducted due to the unavailability of a serial number.(b)(4).Per the instructions for use, the user is advised the following; inspect all equipment for proper operation.To insert the staple cartridge, ensure the handpiece is in the safe position by sliding the safety lever upward.Choose the appropriate size staple cartridge to correspond to the previously selected staple drive attachment.Align the staple cartridge with the cartridge well of the staple drive attachment.Push the staple cartridge wing lock through the matching opening inside the cartridge well.Twist the wing lock 90 deg to lock it into place.A determination for further investigation has been initiated.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: STAPLIZER HANDPIECE
• Type of Device: TENDON/LIGAMENT STAPLER
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 8387984
• MDR Text Key: 138237462
• Report Number: 1017294-2019-00021
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• PMA/PMN Number: K840566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: T100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2019
• Patient Sequence Number: 1