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

Catalog Number 22-4038

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/11/2018

Event Type  malfunction  

Event Description

It was reported that the device broke between handle and shaft.No significant delay or patient injury reported.

Manufacturer Narrative

The returned instrument, intended for use in treatment, was returned for evaluation.There was a relationship found between the device and the reported incident.Visual inspection shows a device which was returned deployed.The instrument was returned broken with a bent shaft and with an open bracket.There were no manufacturing abnormalities found on the device.During functional evaluation the trigger lock button activation was tested and performed as intended.The complaint was verified however the root cause could not be defined with certainty.Factors unrelated to the design and manufacture of the device which could have contributed to the complaint event are excessive force should not be applied to the device and its levers when manipulating soft tissue, bone, or hard objects.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

Manufacturer Narrative

The reported disposable firstpass suture passer device, intended for use in treatment, was not returned for evaluation.Attempts were made to retrieve the product and product has yet to be received.If product is received at a later date, this complaint will get reopened and product evaluation processed accordingly.Without the reported product a visual evaluation cannot be performed and customers complaint cannot be confirmed.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: 7587517
• MDR Text Key: 111159367
• Report Number: 3006524618-2018-00306
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 00817470012309
• UDI-Public: (01)00817470012309(17)181231(10)1130140
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 22-4038
• Device Lot Number: 1130140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Initial Date Manufacturer Received: 05/16/2018
• Initial Date FDA Received: 06/11/2018
• Supplement Dates Manufacturer Received: 07/11/2018; 08/23/2018
• Supplement Dates FDA Received: 07/12/2018; 08/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1