MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX TI 2.8 ULTRABRAID; STAPLE, FIXATION, BONE

Catalog Number 72200750

Device Problem Output Problem (3005)

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

Event Date 03/29/2019

Event Type  malfunction  

Event Description

It was reported that a twinfix titanium 2.8 ultrabraid had an unknown failure.There was a delay of more than 2 hours, no patient injuries reported.It is unknown the failure of the device.

Manufacturer Narrative

Visual inspection and functional testing could not be performed because the devices in question have not been returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product or the pertinent clinical details to consider.As such the complaint is being closed without conclusion.

Manufacturer Narrative

Four twinfix ti 2.8 suture anchor inserters were returned for evaluation.The anchors and sutures were not returned for examination.Visual assessment of the inserters showed no abnormalities.It is difficult to perform an accurate evaluation of a failure without having the entire failed product or the pertinent clinical details to consider.As such the complaint is being closed without conclusion.If new information is received in the future, this complaint can be re opened.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: TWINFIX TI 2.8 ULTRABRAID
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8541898
• MDR Text Key: 142949523
• Report Number: 1219602-2019-00455
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 03596010584472
• UDI-Public: 03596010584472
• Combination Product (y/n): N
• PMA/PMN Number: K972326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2022
• Device Catalogue Number: 72200750
• Device Lot Number: 50690426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Date Manufacturer Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1