MAUDE Adverse Event Report: SMITH & NEPHEW, INC. O*KNOT MANIPULAT,FULL LOOP; ACCESSORIES,ARTHROSCOPIC

Catalog Number 7209146

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

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

Event Date 10/28/2014

Event Type  malfunction  

Manufacturer Narrative

Visual assessment of the device confirmed the reported complaint of breakage.The distal tip has broken off and was not returned for evaluation.The break area shows evidence of plastic deformation consistent with forces that have accumulated over the life time (7 years) of the device until they were sufficient to cause a fracture.There are no indications that would suggest that the device did not meet product specifications upon release into distribution.

Event Description

It was reported that the tip snapped off of the device.Healthcare professional was able to remove the piece with a grasper, and another knot manipulator was able to be used to successfully complete the procedure.Healthcare professional was pressing down on the device, when the tip broke.No other complications were noted.

• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5964376
• MDR Text Key: 55466982
• Report Number: 1219602-2016-00729
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/02/2014

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 Catalogue Number: 7209146
• Device Lot Number: 50215616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/02/2014
• Initial Date FDA Received: 09/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2007
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1