MAUDE Adverse Event Report: ARTHROCARE CORP. SMARTSTITCH PP CONNECTOR; ACCESSORIES,ARTHROSCOPIC

Catalog Number OM-8010

Device Problem Retraction Problem (1536)

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

Event Date 07/20/2016

Event Type  malfunction  

Manufacturer Narrative

The associated complaint device will not be returned for evaluation.Without the actual product involved, the complaint cannot be confirmed, nor can a root cause be determined with confidence.A review of manufacturing records could not be performed as no lot number was provided.There are no indications to suggest the device did not meet product specifications upon release into distribution.No further actions are required at this time.

Event Description

It was alleged that while attempting to pass the suture through the cuff, the needles on the perfect passer connector would not retract.Surgeon used wire cutters to cut the needles, removed all metal from the patient and successfully completed the procedure with a back-up device.No patient injury or other complications were reported.

Manufacturer Narrative

The reported device was returned for evaluation and was intended for treatment.There was a relationship found between the returned device and the reported incident.Visual inspection of the device found that connector was received with a suture cartridge attached.The needles were fired, but they could not be retracted.The needles were cut off and the needle pushrod is broken.Functional evaluation of the returned connector was not performed due to the damage condition of the device.The complaint was confirmed, however, a root cause could not be determined.This device is concomitant with smartstitch handle.Potential factors unrelated to the manufacture or design of the device which could have contributed to the reported event includes: tensioning the suture knobs prior to snaring the suture may compromise the suture snare.The implant system requires tension to be distributed through both suture legs to achieve suture lock deployment.The use of a locking suture stitch may cause tensioning to be more difficult due to the inability of the suture legs to move freely through the tendon.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: SMARTSTITCH PP CONNECTOR
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• 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; austin, TX 78735 ; 5123585706
• MDR Report Key: 5857263
• MDR Text Key: 52437290
• Report Number: 3006524618-2016-00195
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K123268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: OM-8010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1