MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWNFX TI 6.5 PRLD ULTRBRD; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 7210709

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 06/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

It was reported that during an open rcr procedure, the suture came loose from one of the two implanted anchors when the surgeon tied the knot.The device was not removed leaving an unsecured anchor in the patient.A backup anchor was used to provide adequate fixation and complete the procedure.No patient injury or complications were reported.

Manufacturer Narrative

Examination was not possible, as the device was not returned.A review of the device history record was performed which confirmed no inconsistencies.

• Brand Name: TWNFX TI 6.5 PRLD ULTRBRD
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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: 5802836
• MDR Text Key: 50717732
• Report Number: 1219602-2016-00396
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K053344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/20/2016

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: 02/12/2021
• Device Catalogue Number: 7210709
• Device Lot Number: 50585971
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2016
• Initial Date FDA Received: 07/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2016
• 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