MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX 2.8 TI W/NDL,2#2-0 ULTRABRAID; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72202067
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/29/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, after completing the insertion of the screw, they started to perform the ligamentoraphy to the deltoid tendon.They started to suture in the middle of this procedure and doctor passed one of the needles through the tendon and its extension.In the middle of this maneuver, they observed that the suture was not passing completely, it was observed that the needle apparently dislodged from the suture, since it did not pass in its entirety and the guide was attached to the tendon, it was possible to remove the needle with a kelly clamps.They checked the needle with its suture at in detail and the needle was broken in its proximal part.It is unknown if backup was available and how the issue was resolved but no patient injury or other complications were reported.There was no delay reported.
Additional Manufacturer Narrative
Visual inspection and functional testing could not be performed because the device in question has 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.As such the complaint is being closed without conclusion.However, if the product is returned in the future the complaint can be reopened and evaluated.

• Brand Name: TWINFIX 2.8 TI W/NDL,2#2-0 ULTRABRAID
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8262103
• Report Number: 1219602-2019-00088
• Device Sequence Number: 2126261
• Product Code: MBI
• UDI-Device Identifier: 03596010619112
• UDI-Public: 03596010619112
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K972326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/02/2023
• Device Catalogue Number: 72202067
• Device Lot Number: 50713288
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/29/2018
• Supplement Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 01/18/2019
• Supplement Report FDA Received Date: 02/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR