MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA 6.5MM W/3 UB; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72202900
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during shoulder arthroscopy procedure, the device was not working.A backup device was available to complete the procedure with no delay or patient injuries.Preliminary investigation has concluded that this device was submitted to torque and force, which caused the distal portion of the device to break, making it a reportable event.
Additional Manufacturer Narrative
One 72202900 twinfix¿ ultra ti 6.5mm suture anchor product used for treatment, was partially returned for evaluation.The complaint stated: ¿the device was not working.¿ the inserter device was not returned.The anchor was not returned.Small segments of suture were returned jammed and knotted inside a broken distal section of the inserter shaft.There was another mid shaft portion returned.That was the extent of the return.The allegation could not be confirmed.Instruction for use documentation is quite specific and confirms instructions, precautionary statements and recommendations for proper use of product.The returned segments of shaft were quite damaged.There were dings, gouges, flattening and instrument bite marks on the sections.Damage is consistent with force and torque.Site prep is critical to a successful implementation.Instructions for use for this product has technique driven instructions and cautions: ¿use of excessive force during insertion can cause failure of the suture anchor or insertion device.A two-finger ao technique should be used to insert the anchor.If more torque is required to insert the anchor, stop and ensure that the anchor size, drill hole size, and depth are correct for the bone conditions encountered.It may be necessary to reduce the anchor size or increase the drill 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.Factors that may affect device performance include: device storage, device ability, surgical ability, procedure location and tissue condition.No root cause related to the manufacture of the device was confirmed.Product met specifications upon release to distribution.

• Brand Name: TWINFIX ULTRA 6.5MM W/3 UB
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8976731
• Report Number: 1219602-2019-01098
• Device Sequence Number: 221313
• Product Code: MBI
• UDI-Device Identifier: 03596010652324
• UDI-Public: 03596010652324
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K100159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• 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: 01/12/2023
• Device Catalogue Number: 72202900
• Device Lot Number: 2009757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 09/09/2019
• 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