MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA PK 5.5MM W/3UB-WHT,BL &BLK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72202600
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, the tip of the anchor broke.The procedure was successfully completed with no significant delay using a back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
One 5.5 twinfix ultra pk anchor assembly was returned for evaluation.Visual assessment of the anchor confirmed the reported breakage.The anchor has broken at the suture eyelet.Dimensional assessment of the anchors major diameter found it met print specifications.The inserter tines that interface with the anchor were also examined and noted to be bent and twisted.The condition of the anchor indicates it was subjected to excessive force during insertion.
Additional Manufacturer Narrative
Visual inspection and functional testing could not be performed because the device in question has not been returned evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product or the pertinent clinical details to consider.As such the complaint is being closed without conclusion.

• Brand Name: TWINFIX ULTRA PK 5.5MM W/3UB-WHT,BL &BLK
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8198165
• Report Number: 1219602-2018-01796
• Device Sequence Number: 14023317
• Product Code: MBI
• UDI-Device Identifier: 03596010647481
• UDI-Public: 03596010647481
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K093228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2019

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: 12/06/2022
• Device Catalogue Number: 72202600
• Device Lot Number: 50701476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 02/05/2019; 03/11/2019
• Initial Report FDA Received Date: 12/26/2018
• Supplement Report FDA Received Date: 02/06/2019; 03/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1