MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA PK 5.5MM W/ 2 UB-BL &BLK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72202625
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 an unknown procedure, the anchor did not maintain the structural integrity when screwing into the humeral head of the patient, cracking under pressure of cortical bone, despite reportedly dilating bone correctly with 3.8 mm tapered awl dilator.The procedure was completed with a back up device with no delay or patient injury reported.
Additional Manufacturer Narrative
One 72202625 twinfix ultra pk 5.5mm suture anchor was reported on.The failed device used for treatment, was not returned, but rather, seven new and unopened devices were returned to represent the allegation.The complaint stated: ¿the anchor did not maintain the structural integrity when screwing into the humeral head of the patient, cracking under pressure of cortical bone, despite reportedly dilating bone correctly with 3.8 mm tapered awl dilator.¿ a sample device was tested.It was inserted, seated flush and properly.There were no unusual observations.It was then tested in an inferior hole where it was apparent that excess torque was required to rotate.The anchor did not seat flush.With continued rotations, the anchor would have become damaged or fractured.Instruction for use (ifu) documentation is quite specific and confirms instructions, precautionary statements and recommendations for proper use of product.Per ifu: ¿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.Caution: 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.¿ product met specifications upon release to distribution.No root cause related to the manufacture of this device was confirmed.
Event or Problem Description
It was reported that, during a rotator cuff repair, the anchor did not maintain the structural integrity when screwing into the humeral head of the patient, cracking under pressure of cortical bone, despite reportedly dilating bone correctly with 3.8 mm tapered awl dilator.All the pieces were removed.The procedure was completed with a back up device with no significant delay or patient injury reported.

• Brand Name: TWINFIX ULTRA PK 5.5MM W/ 2 UB-BL &BLK
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8954188
• Report Number: 1219602-2019-01080
• Device Sequence Number: 19485358
• Product Code: MBI
• UDI-Device Identifier: 03596010647535
• UDI-Public: 03596010647535
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2019

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: 05/04/2023
• Device Catalogue Number: 72202625
• Device Lot Number: 2013988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 09/05/2019; 10/03/2019
• Initial Report FDA Received Date: 09/02/2019
• Supplement Report FDA Received Date: 09/05/2019; 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1