MAUDE Adverse Event Report: ARTHROCARE CORP. DISP FIRSTPASS STR PASSR SELF; PASSER

Catalog Number 22-4038

Device Problems Misfire (2532); Physical Resistance/Sticking (4012)

Patient Problem No Code Available (3191)

Event Date 03/20/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that, during a shoulder arthroscopy, the firstpass suture passer needle fired outside the jaw instead of through the suture capture; both the needle and the jaw got stuck in the locked position, with the tendon in between.As a result of the incident, it had to be used a gold awl to open up the jaw of the passer.The tendon was frayed after its release.A back-up device was available to complete the procedure.Neither surgical delay nor patient injuries were stated.

Manufacturer Narrative

The returned device, intended for use in treatment, was returned as an mdr for evaluation.There was a relationship found between the devices and the reported incident.Visual inspection shows no manufacturing abnormalities on the device.The instrument was returned with a closed bracket.The needle and the top jaw at distal end is strongly bent and does not perform any more.The trigger stuck on the first step and could not be released; during function evaluation, the trigger on the instrument could not be released due to the broken top jaw and a bent and broken needle.The complaint was not verified and the root cause could not be defined with certainty.Factors that have nothing to do with the design and manufacture of the devices and that may have contributed to the complaint event are described in the instructions for use in the instructions for use included with the device for setting up and using the device.Excessive force is be applied to the device when manipulating soft tissue, bone, or hard objects.Instrument used as a lever for manipulating hard tissue or bone; there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: DISP FIRSTPASS STR PASSR SELF
• Type of Device: PASSER
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8491544
• MDR Text Key: 141200070
• Report Number: 3006524618-2019-00172
• Device Sequence Number: 1
• Product Code: HWQ
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2021
• Device Catalogue Number: 22-4038
• Device Lot Number: 2023577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Date Manufacturer Received: 06/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other