MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWNFX TI 6.5 PRLD ULTRBRD; STAPLE, FIXATION, BONE

Model Number 7210709

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/16/2018

Event Type  malfunction  

Event Description

It was reporte that when the anchor was deployed and took out the needles they loosened form the suture.Needles with eyelet were used to complete the procedure.No significant delay or patient injury reported.

Manufacturer Narrative

Due to no product return the complaint could not be confirmed.Definitive conclusions, accurate investigation and evaluation are not possible without product to evaluate.

• Brand Name: TWNFX TI 6.5 PRLD ULTRBRD
• Type of Device: STAPLE, FIXATION, BONE
• 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 ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7430569
• MDR Text Key: 105644107
• Report Number: 1219602-2018-00432
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 03596010532213
• UDI-Public: (01)03596010532213(17)220802(10)50677905
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K972326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7210709
• Device Catalogue Number: 7210709
• Device Lot Number: 50677905
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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