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

Model Number	72202615
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zip code: (b)(6).
Event or Problem Description
It was reported that during an ankle tendon achilles repair, when using a twinfix ultra, the tip of the suture anchor broke when being inserting into the patient metatarsal bone.The pieces were removed from the patient.The procedure was completed without significant delay using a back-up device in the same bone hole.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10.H3, h6: the reported 5.5 twinfix ultra pk anchor w/needles, used 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 tip of the anchor broke during insertion.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive forces applied during use.Not preparing the insertion site with the recommended prep device.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: TF ULTRA 2 UBRAID AND NDLS 5.5MM PK
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9566309
• Report Number: 1219602-2020-00056
• Device Sequence Number: 2490568
• Product Code: MBI
• UDI-Device Identifier: 03596010656209
• UDI-Public: 03596010656209
• Combination Product (Y/N): N
• PMA/510(K) Number: K093228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2020

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: 05/14/2024
• Device Model Number: 72202615
• Device Catalogue Number: 72202615
• Device Lot Number: 2030928
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 02/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR