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

Catalog Number	72202618
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a rotator cuff repair surgery, while trying to put a bone transection point, the twinfix needle was stuck; when attempting to remove it, the suture detached from the needle.In consequence, the physician decided to leave the needle inside of the patient.It is unknown if/how the procedure was finished.The surgery was not delayed.The patient was not injured.
Additional Manufacturer Narrative
Report source: other specify: colombia.One 72202618 twinfix ultra titanium 5.5mm anchor device reported on.The product was used for treatment but not returned for evaluation.Physical conclusions, full investigation and evaluation were limited.Factors affecting device performance include: device ability, surgical ability, implant location, tissue condition and surgical site preparation according to instructions for use.Influences that may compromise product integrity include: site prep with alternate or without recommended instruments.Use of excess force.Difficulty establishing and maintaining axial alignment to prepared insertion site.Instructions for use gives specific instruction and has precautionary statements and recommendations for proper use of product which includes a chart of size and bone condition specific prep instruments.Per instructions for use: ¿it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.Read these instructions completely prior to use.Remove the awl from the insertion site by tapping lightly on the underside of the handle.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.Recommended prep instrument for the 5.5mm anchor used on normal bone condition is a 3.8mm tapered awl and a 4.5mm spade tip drill.No root cause associated with the manufacture of this device was established.Product met specs upon release to distribution.

• Brand Name: TF ULTRA 2 UBRAID AND NDLS 5.5MM TI
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8900831
• Report Number: 1219602-2019-00970
• Device Sequence Number: 16676402
• Product Code: MBI
• UDI-Device Identifier: 03596010656131
• UDI-Public: 03596010656131
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K100159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2019

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: 04/09/2024
• Device Catalogue Number: 72202618
• Device Lot Number: 2030932
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 08/16/2019
• Supplement Report FDA Received Date: 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR