MAUDE Adverse Event Report: ARTHROCARE CORP. SMARTSTITCH PERFECTPASSER SUTURE CARTRID; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	OM-8176EA
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that, during a left shoulder cuff repair surgery, it was used: (a) 1 anchor x om-6500 speedscrew lot 2001966, with (b) 1 x om-8176ea suture magnum wire lot 2008074; despite a good use of the anchor on the tension of the sutures, the sutures broke without logical explanation.The procedure was finished in mini-open modality and using a competitor device.There is not reference to whether there was a delay in the surgery or not.No patient injury has been reported.
Additional Manufacturer Narrative
Part number: om-6500 speedscrew & lot 2001966.
Additional Manufacturer Narrative
The returned device, intended for use in treatment, was returned as an mdr for evaluation.There was no relationship found between the device and the reported incident.Visual inspection of the returned opus speedscrew implant shows a deployed device with an implant which is not detached or damaged.The instrument was returned with the function switch towards to the ¿black¿ dot.At distal end the implant visually show contamination with dried parts of tissue.No manufacturing anomalies were identified.During functional evaluation the partial moved suture limb can be tensioned.Both suture limbs were reeled into the wheels.The function switch could be set towards the ¿deploy¿ position and the implant could be detached by turning the activation knob 3-times clockwise as specified.The complaint was not verified and the root cause could not be determined with certainty.Factors unrelated to the design or manufacture of the device which could have contributed to the complaint event includes: (1) there may have been misalignment of the device when inserting (2) bend and applying excessive torque could cause reduced functionality.The instructions for use was reviewed and determined to have precautionary statements and instructions in regards to the use of the device to avoid damage and non-functionality.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: SMARTSTITCH PERFECTPASSER SUTURE CARTRID
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8156353
• Report Number: 3006524618-2018-00648
• Device Sequence Number: 2288001
• Product Code: GAT
• UDI-Device Identifier: 00817470005837
• UDI-Public: 00817470005837
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K123268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/22/2020
• Device Catalogue Number: OM-8176EA
• Device Lot Number: 2008074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 12/03/2018; 03/01/2019
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 01/23/2019; 03/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PART NUMBER: OM-6500 SPEEDSCREW & LOT 2001966
• Patient Age: 60 YR