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 Consequences Or Impact To Patient (2199)
Date of Event	03/30/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anchor broke during insertion into patient humerus.A 3.8mm dilator was used prior implantation of the suture anchor.No significant delay or patient injury reported.
Additional Manufacturer Narrative
Due to no product return the complaint could not be confirmed.Definitive conclusions, accurate investigation and evaluation are not possible without product to evaluate.

• 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: 7463225
• Report Number: 1219602-2018-00491
• Device Sequence Number: 13817135
• Product Code: MBI
• UDI-Device Identifier: 03596010656209
• UDI-Public: (01)03596010656209(17)230126(10)50710601
• 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: 01/26/2023
• Device Model Number: 72202615
• Device Catalogue Number: 72202615
• Device Lot Number: 50710601
• 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: 04/25/2018
• 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