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

Model Number 72202618

Device Problems Break (1069); Loose or Intermittent Connection (1371)

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

Event Date 04/03/2018

Event Type  malfunction  

Event Description

It was reported that during the procedure the anchor was implanted properly, at the moment of removing the insertion handle the sutures were found damaged and loose of the implant.Only the screw of the anchor stayed inside the patient, this was removed with a wirecutter of the hospital.No delay or patient injury reported.

Manufacturer Narrative

Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.

• 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: 7470893
• MDR Text Key: 106886887
• Report Number: 1219602-2018-00504
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010656131
• UDI-Public: (01)03596010656131(17)220814(10)50679888
• Combination Product (y/n): N
• 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: 05/18/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2022
• Device Model Number: 72202618
• Device Catalogue Number: 72202618
• Device Lot Number: 50679888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2018
• Initial Date FDA Received: 04/27/2018
• Supplement Dates Manufacturer Received: 05/18/2018
• Supplement Dates FDA Received: 05/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2017
• 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