MAUDE Adverse Event Report: ARTHROCARE CORP. UNKNOWN; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72202462

Device Problems Difficult to Remove (1528); Device Or Device Fragments Location Unknown (2590)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/16/2016

Event Type  Injury  

Manufacturer Narrative

Event Description

It was reported that during preparation for a procedure using an inspace balloon the surgeon encountered an anchor from a previous surgery, that created an obstacle for the current procedure.The surgeon removed the anchor with graspers, however he dropped the anchor and lost it inside the patient.The surgeon was uncertain if this was an arthrocare anchor, but thought that it looked similar to a magnum anchor.The product brand could not be confirmed.No patient complications have been reported regarding this incident.

Manufacturer Narrative

Visual, dimensional, and functional testing could not be performed since the device was not returned for evaluation.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.As stated in the reported event, the implant was removed to prepare for another procedure but was lost inside the patient.Cytotoxicity/biocompatibility testing for magnum anchors found that the devices met the acceptance criteria for the required biocompatibility tests and affirmed no toxic effect of materials.There are no indications to suggest the device did not meet product specifications upon release into distribution.

• Brand Name: UNKNOWN
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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
• MDR Report Key: 5505616
• MDR Text Key: 40532288
• Report Number: 3006524618-2016-00061
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 72202462
• Device Catalogue Number: 72202462
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other