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

Catalog Number 22-4038

Device Problem Mechanical Jam (2983)

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

Event Date 10/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the suture passer kept jamming during the procedure.Tendon was not necessarily thick or difficult to handle.No backup device was readily available therefore a competitive device had to be used instead.No delay or patient injuries were reported.

Manufacturer Narrative

Device was not returned for evaluation.A relationship between the product and reported incident cannot be established as the product was not returned.Without the reported product a visual and functional evaluation cannot be performed and customers complaint cannot be confirmed.From the information provided, the suture passer kept jamming during the procedure.An exact root cause cannot be determined without evaluation of the device; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: (1) excessive leverage used to manipulate tissue.Excessive leverage used to manipulate tissue can result in failure.An exact root cause cannot be determined with confidence as no product was received for evaluation.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.Complaint history search revealed no additional complaints for this production lot.

• Brand Name: DISP FIRSTPASS STR PASSR SELF
• Type of Device: PASSER
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: jim gonzales ; 7000 w. william cannon drive; austin, TX 78735
• MDR Report Key: 6933077
• MDR Text Key: 90163520
• Report Number: 3006524618-2017-00313
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 00817470012309
• UDI-Public: (01)00817470012309(17)200229(10)1185970
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 22-4038
• Device Lot Number: 1185970
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1