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

Model Number 72200752

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 11/13/2019

Event Type  malfunction  

Event Description

It was reported that, 20 days after an open reduction and fixation procedure with a twinfix, swelling, redness and secretion overflow were found over the incision site.On 1/16/20 the implant was removed from within the patient.The fracture line is no longer visible.The patient's outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: additional information on b5.H11: correction on b2.

Event Description

It was reported that, 20 days after an open reduction and fixation procedure with a twinfix, swelling, redness and secretion overflow were found over the incision site.On (b)(6) 2020 the implant was removed from within the patient.The fracture line is no longer visible.The patient has recovered.

Manufacturer Narrative

H6: the reported 3.5mmtwinfix ti, used in treatment, will not be returned for evaluation, however photographs and an x-ray were provided.The photographs were reviewed and it was confirmed that the anchor was removed from the patient.Due to the nature of the complaint a review of the sterility records for the lot number in question was performed which confirmed that the product was sterilized per the standard terminal sterilization process.All parameters of the sterilization cycle conformed to the validated parameters.A review of the manufacturing, risk documents and complaint records was performed, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.Further investigation is not warranted at this time.In conclusion, the root cause of the infection cannot be definitively concluded but this could support the migration of the anchor that required removal.The fracture was healed and no further impact is expected as it was reported that the patient has recovered.

• 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: 9662563
• MDR Text Key: 177608887
• Report Number: 1219602-2020-00163
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2023
• Device Model Number: 72200752
• Device Catalogue Number: 72200752
• Device Lot Number: 50763854
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 15 YR