MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA 6.5MM W/3 UB; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72202900
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 6.5 twinfix ultra ti anchor assembly was returned for evaluation.Visual assessment of the device shows the inserter tip has broken off at the weldment.The broken portion was not returned.Examination of the weld bead characteristics confirmed adequate penetration between the welded components.Examination of the anchor confirmed the presence of human matter (bone) in its threads.The proximal end of the anchor is damaged from what looks like some type of grasping device.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: use of excessive force during insertion can cause failure of the suture anchor or insertion device.A two-finger ao technique should be used to insert the anchor.In hard bone, it may be necessary to create a pilot hole.The instruction for use was reviewed and was 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.
Event or Problem Description
It was reported that during an unknown procedure the device failed.No surgical delay or patient injuries were reported and a back-up device was available.Results of investigation found the anchor to be broken and with presence of human matter in its threads.As a result, it can be concluded that anchor broke in the patient which makes it a reportable event.

• Brand Name: TWINFIX ULTRA 6.5MM W/3 UB
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8654387
• Report Number: 1219602-2019-00644
• Device Sequence Number: 2285987
• Product Code: MBI
• UDI-Device Identifier: 03596010652324
• UDI-Public: 03596010652324
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K100159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/30/2019

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: 03/02/2024
• Device Catalogue Number: 72202900
• Device Lot Number: 2029247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 05/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1