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

Model Number OM-8010

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2018

Event Type  malfunction  

Event Description

It was reported that the metal jaw of passer broke off.It was found in the drape, did not break inside the shoulder joint.There was an extended procedure time as a result of the malfunction.A backup device was available to complete the procedure with no patient injuries.

Manufacturer Narrative

It was reported that the metal jaw of the passer broke off.It was found in the drape, did not break inside the shoulder joint but there was an extended procedure time as a result of the malfunction.A backup device was available to complete the procedure with no patient injuries.

Manufacturer Narrative

Surgical delay in and of itself does not necessitate reporting of the clinical event.However, a delay greater than 30 minutes may result in extended exposure to anesthesia which may present additional patient risk or, in extreme cases, may necessitate medical intervention to alleviate the patient condition.This event is considered reportable pursuant to 21 c.F.R.§803.Consideration of the patient impact of any surgical delay must be considered on a case-by-case basis, and a medical opinion should be sought when there is any instance of doubt.

• 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: 7302874
• MDR Text Key: 101581871
• Report Number: 3006524618-2018-00096
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00817470006971
• UDI-Public: (01)00817470006971(17)200131(10)1182578
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: OM-8010
• Device Catalogue Number: OM-8010
• Device Lot Number: 1182578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2017
• 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