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

Model Number OM-8010

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

Initial reporter's international zip code: (b)(6).

Event Description

It was reported that the top jaw disengaged from the device when clamped.No fragments were left in the patient.A backup device was available to complete the procedure with no major delay or patient injuries.

Manufacturer Narrative

The reported smartstitch perfectpasser connector, intended for use in treatment, 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 top jaw disengaged from the device when clamped.An exact root cause cannot be determined with confidence; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: excessive force.Excessive force applied to the device can result in damage to the device and device failure.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 drive; austin, TX 78735
• MDR Report Key: 7316887
• MDR Text Key: 101870323
• Report Number: 3006524618-2018-00108
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00817470006971
• UDI-Public: (01)00817470006971(17)200331(10)1187254
• Combination Product (y/n): N
• PMA/PMN Number: K123268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2018

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: 03/31/2020
• Device Model Number: OM-8010
• Device Catalogue Number: OM-8010
• Device Lot Number: 1187254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2018
• Initial Date FDA Received: 03/06/2018
• Supplement Dates Manufacturer Received: 03/27/2018
• Supplement Dates FDA Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2017
• 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