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

Model Number	72202615
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/30/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anchors broken during insertion into patient humerus (shoulder rotator cuff repair).The 3.8mm dilator used prior implantation of the suture anchors.Both 1st and 2nd anchors broken during screwing into humerus.Twinfix ti 5.0 mm suture anchor was used then.No patient injury was reported.
Additional Manufacturer Narrative
Examination is not possible, as the devices will not be returned, however photographs were supplied.Review of the photographs confirmed the reported breakage.Both anchors are broken at their suture eyelet.The suture and needles are free from their handle.Without the return of the devices we are unable to determine a root cause.

• Brand Name: TF ULTRA, 2 UBRAID AND NDLS, 5.5MM PK
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7466571
• Report Number: 1219602-2018-00500
• Device Sequence Number: 1642786
• Product Code: MBI
• UDI-Device Identifier: 03596010656209
• UDI-Public: (01)03596010656209(17)221031(10)50693993
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K093228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 72202615
• Device Catalogue Number: 72202615
• Device Lot Number: 50693993
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/30/2018
• Supplement Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 04/26/2018
• Supplement Report FDA Received Date: 05/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1