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 Information (3190)
Date of Event	04/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a rotator cuff repair surgery, upon insert the anchor into the patient, the tip of the anchor broke and then it was removed from patient with a knife and artery clamp.Backup device was available to complete the procedure.No significant delay and no patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: one 72202615 twinfix ultra pk 5.5mm suture anchor used for treatment, was not returned for evaluation.Instructions for use contains recommendations and precautionary statements for proper use of product.Due to unavailability, the evaluation was limited.If further evidence becomes available, the complaint may be revisited.Factors that could affect device performance include: device storage, device ability, surgical ability, procedure location and tissue condition.Influences that might compromise product performance or integrity include: 1) non-compliance or deviation from technique driven instructions.2) alternate prep method or instruments used.3) unexpected bone density/condition.4) incomplete anchor insertion.5) loss of or lack of axial alignment.Per instructions for use caution: use of excessive force during insertion can cause failure of the suture anchor or insertion device.If more torque is required to insert the anchor, stop and ensure that the hole size and depth are correct for the bone conditions encountered.It may be necessary to reduce the anchor size or increase the hole size to achieve optimal insertion force.It is the responsibility of the surgeon to determine the patient¿s bone condition, appropriately prepare the insertion site, and determine the suitability of the implant for the procedure.Complaint history review indicated no similar allegations for the lot number reported.Batch review indicated no condition, product or procedure failure that supported the allegation.Product met specifications upon release to 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 blvd.; mansfield MA 02048
• MDR Report Key: 10080830
• Report Number: 1219602-2020-00811
• Device Sequence Number: 3924073
• Product Code: MBI
• UDI-Device Identifier: 03596010656209
• UDI-Public: 3596010656209
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/12/2024
• Device Catalogue Number: 72202615
• Device Lot Number: 2045813
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2020
• Supplement Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 05/21/2020
• Supplement Report FDA Received Date: 06/29/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention