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

Catalog Number	72202615
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
International zip code: (b)(6).
Event or Problem Description
It was reported that during a procedure, the surgeon tapped the hole for the twinfix pk anchor with the 4.5mm healicoil tap as per her preference.When she turned the anchor into the pre-tapped hole, the anchor broke in half.Another anchor was provided, the 5.5mm twinfix awl was used and the second anchor worked perfectly.There was no significant delay and no patient injuries.
Additional Manufacturer Narrative
One 5.5 twinfix ultra w/needles was returned for evaluation.Visual assessment of the device confirmed the reported breakage.The anchor has broken in above the suture eyelet.There are pieces missing from the anchor that were not returned.The clinical details were reviewed, and it was identified that the patient had hard bone and that a 4.5mm healicoil tap was used to prepare the insertion site.
Additional Manufacturer Narrative
Additional information.
Event or Problem Description
It was reported that during a procedure, the surgeon tapped the hole for the twinfix pk anchor with the 4.5mm healicoil tap as per her preference.When she turned the anchor into the pre-tapped hole, the anchor broke in half.The pieces were removed from patient and another anchor was provided.The 5.5mm twinfix awl was used and the second anchor worked perfectly with no additional bone hole required.There was no significant delay or patient injuries.

• 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: 8155657
• Report Number: 1219602-2018-01740
• Device Sequence Number: 13952419
• Product Code: MBI
• UDI-Device Identifier: 03596010656209
• UDI-Public: 03596010656209
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 01/31/2019

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: 09/14/2023
• Device Catalogue Number: 72202615
• Device Lot Number: 50758791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 01/18/2019; 01/30/2019
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 01/21/2019; 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1