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

Catalog Number	72202900
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a rotator cuff repair the inserter broke inside the patient, all the pieces were removed.The procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
One 72202900 twinfix¿ ultra ti 6.5mm suture anchor product returned.The complaint stated: ¿the inserter broke inside the patient.¿ the inserter was returned with a fractured distal end.The shaft and anchor mating portion had a fractured weld seam.Both have evidence of weld remaining.The inserter shaft tip has been slightly flared from force.The titanium anchor is visibly damaged.There are dings, gouges and bites to the threads.The chips are absent.The damage is consistent with entanglement with another instrument or device.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.Instruction for use documentation is quite specific and confirms instructions, precautionary statements and recommendations for proper use of product.No root cause related to the manufacture of this device was confirmed.

• 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: 8646929
• Report Number: 1219602-2019-00624
• Device Sequence Number: 1832243
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2019

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: 03/02/2024
• Device Catalogue Number: 72202900
• Device Lot Number: 2029247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 05/28/2019
• Supplement Report FDA Received Date: 05/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1