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

Catalog Number	72202615
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during the surgery the anchor broke its tip upon insertion into the bone, with minimal force applied.The broken piece was removed from the patient with a grasper.A backup device was used to complete the surgery.No significant delay or patient injury reported.
Additional Manufacturer Narrative
The 5.5 twinfix ultra pk anchor w/needles assemblies in question will not be returned for evaluation, however three unused devices from the same manufactured lot were returned for examination.One device was opened for examination.Visual assessment of the device showed no abnormalities.Dimensional assessment of the device confirmed they met print specifications.Without the reported product in question and pertinent clinical details an exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: not preparing the insertion site properly, off axis insertion of the anchor.The instruction for use was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• 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: 9112296
• Report Number: 1219602-2019-01165
• Device Sequence Number: 1749463
• Product Code: MBI
• UDI-Device Identifier: 03596010656209
• UDI-Public: 03596010656209
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K093228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2019

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: 11/30/2023
• Device Catalogue Number: 72202615
• Device Lot Number: 50773215
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 10/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1