MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX TI 3.5 ULTRABRAID; STAPLE, FIXATION, BONE

Catalog Number 72200752

Device Problem Insufficient Information (3190)

Patient Problem Inflammation (1932)

Event Date 02/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that, after a medial collateral ligament repair surgery, in which the twinfix was used in order to enhance the stability of the elbow joint, the wound did not heal for a long time: there was redness and exudation.The healthcare facility changed the patient medication several times, but the wound would not be cured.The patient outcome is still unknown.

Manufacturer Narrative

The reported 3.5mm twinfix ti assembly intended for use in treatment, will not be returned for evaluation.Without the reported product a visual evaluation cannot be performed.From the information provided, the patient experienced post-op inflammation.An exact root cause cannot be determined with confidence.Based on the nature of the complaint, a review of the sterility records was conducted.The product was sterilized per specifications.All process parameters were confirmed to be within specification.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: TWINFIX TI 3.5 ULTRABRAID
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8722136
• MDR Text Key: 148765850
• Report Number: 1219602-2019-00733
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 03596010578921
• UDI-Public: 03596010578921
• Combination Product (y/n): N
• PMA/PMN Number: K972326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2022
• Device Catalogue Number: 72200752
• Device Lot Number: 50687838
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR