MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX TI 5.0 ULTRABRAID; STAPLE, FIXATION, BONE

Model Number 72200755

Device Problems Detachment Of Device Component (1104); Connection Problem (2900)

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

Event Date 03/21/2018

Event Type  malfunction  

Event Description

It was reported that while using a twinfix titanium 5.0 ultrabraid and doing the knot, the thread came out from the anchor.

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: TWINFIX TI 5.0 ULTRABRAID
• 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: 7393496
• MDR Text Key: 104421444
• Report Number: 1219602-2018-00396
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 03596010577986
• UDI-Public: (01)03596010577986(17)221219(10)50703442
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K972326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2022
• Device Model Number: 72200755
• Device Catalogue Number: 72200755
• Device Lot Number: 50703442
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2018
• 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