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

Catalog Number	72202067
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a wrist capsular repair, when we were passing the points through tissue, which did not resist, the needle was deformed until it was almost straight.Additionally, at the time of the knotting, it bursts, it was verified if it was the thread and it was evidenced that it was the needle that burst in its proximal third, leaving the thread with a piece of the needle.However, by continuing with the knotting, the thread bursts 3 times, even without being subjected to high tension.A backup device was available to complete the procedure with no delay or patient injuries.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported 2.8mm twinfix w/needles for use in treatment, will not be returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the needle deformed during use.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force placed on the needle during use.The instruction for use were reviewed and were found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: TWINFIX 2.8 TI W/NDL,2#2-0 ULTRABRAID
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9336626
• Report Number: 1219602-2019-01446
• Device Sequence Number: 13979434
• Product Code: JDR
• 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): 12/11/2019

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: 10/15/2023
• Device Catalogue Number: 72202067
• Device Lot Number: 50764536
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/24/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 12/11/2019
• 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