MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TF ULTRA 2 UBRAID AND NDLS 5.5MM PK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72202615

Device Problem Expiration Date Error (2528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that after a proximal hamstring repair, twinfix ultra device had a labeling issue, since it appeared to be a 4.5mm and it was a 5.5mm.In addition it was noticed that device was used expired.No further complications reported.

Manufacturer Narrative

H10: h3, h6:the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: TF ULTRA 2 UBRAID AND NDLS 5.5MM PK
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 12185541
• MDR Text Key: 262166340
• Report Number: 1219602-2021-01564
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010656209
• UDI-Public: 03596010656209
• Combination Product (y/n): N
• PMA/PMN Number: K093228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2021
• Device Model Number: 72202615
• Device Catalogue Number: 72202615
• Device Lot Number: 50602214
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1