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

Model Number 22-4038

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 04/03/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that, during shoulder surgery, the jaw of the firstpass suture passer could not be opened and stayed locked in close position after triggering the needle.The surgeon pulled it out forcibly and there was slight damage to the patient's rotator cuff.The procedure was successfully completed without significant delay using a back-up device.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h3, h6: the disposable firstpass device, used in treatment, was returned for evaluation.A relationship between the device and reported incident was established.A review of manufacturing records for the reported lot number 2040498 found no non-conformances or anomalies during manufacturing process related to the reported event.Review of the product instructions for use found adequate warnings and precautions to prevent damage to the device during use.Risk management documents were reviewed finding no additional risks that require to be added to the reference document.Clinical evaluation was completed and concluded that without supporting clinical/medical documents, a thorough investigation cannot be performed.Per the intake team; all efforts to obtain additional information regarding this complaint did not provide any results.If additional supporting medical documents are received this complaint will be reassessed.Visual inspection shows no manufacturing abnormalities on the device.The instrument was returned with an closed top bracket.The needle is bent.The first step of the trigger stayed locked in the closed position and cannot be released; the device is damaged.The returned device is a single use device and could not be functional tested; an attempt was made trying to test the basic functions but due to the damages a functional test could not be performed.The complaint was verified.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: (1) excessive force.(2) tissue thickness (3) tip damaged or debris between passes.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: 10009304
• MDR Text Key: 189358804
• Report Number: 3006524618-2020-00222
• 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: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2022
• Device Model Number: 22-4038
• Device Catalogue Number: 22-4038
• Device Lot Number: 2040498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Date Manufacturer Received: 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other