MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TENSIONER, BIOSURE SYNC; ACCESSORIES,ARTHROSCOPIC

Catalog Number 72202754

Device Problem Mechanical Problem (1384)

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

Event Date 03/17/2015

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation and was found to meet design specifications.No problem was found with the device, the reported issue could not be confirmed.(b)(4).

Event Description

It was reported that during a procedure, the device had a bad spring with an inaccurate tension reading.The procedure was completed with a competitive device.No patient injury or complications were reported.

Manufacturer Narrative

A review of the device history record was performed which confirmed no inconsistencies.

• Brand Name: TENSIONER, BIOSURE SYNC
• 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: james gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5784276
• MDR Text Key: 49954676
• Report Number: 1219602-2016-00369
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/26/2015

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: 72202754
• Device Lot Number: 50483245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/26/2015
• Initial Date FDA Received: 07/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1