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

Catalog Number 72202618

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/28/2018

Event Type  malfunction  

Event Description

It was reported that when the anchor was placed in the bone, the anchor was rolled with its thread pitch, so it was removed with a plier.No patient injury was reported.

Manufacturer Narrative

One 5.5 twinfix ultra ti anchor assembly w/needles was returned for evaluation.Visual assessment confirmed the reported complaint.The anchor is deformed at its proximal end.The device ifu recommends a 3.8 mm tapered awl and a 4.5 mm spade tip drill in hard bone for site preparation.If more torque is required to insert the anchor, stop and ensure that the hole size and depth are correct for the bone conditions encountered.It may be necessary to reduce the anchor size or increase the hole size to achieve optimal insertion force.It is the responsibility of the surgeon to determine the patient¿s bone condition, appropriately prepare the insertion site, and determine the suitability of the implant for the procedure.Breakage of the suture anchor can occur if insertion sites are not prepared with appropriate instrumentation prior to implantation.Further investigation is not warranted at this time.

• Brand Name: TF ULTRA, 2 UBRAID AND NDLS, 5.5MM TI
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7547207
• MDR Text Key: 109499376
• Report Number: 1219602-2018-00655
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K100159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2022
• Device Catalogue Number: 72202618
• Device Lot Number: 50691234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 25 YR