MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA PK 5.5MM W/3UB-WHT BL &BLK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72202600
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during shoulder arthroscopy the suture anchor broke.All pieces were removed.The procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10, h2, h3, h6: two 72202600 twinfix ultra pk 5.5mm devices used in treatment, were returned for evaluation.The inserters were returned with handle and spring action functional.Forks were intact but were bent.Anchors and suture were attached to the inserters.One was a partial anchor returned.Distal threads were missing and were not returned.Remaining threads were ragged at the distal tip.The second anchor was whole but was cracked and had burnished distal threads.The tip was bent off axis.Product indicated symptoms of excess torque, loss of axial alignment or inadequate tunnel size would also encourage the symptoms found.Specific prep and use techniques are outlined per instructions for use: 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.Breakage of the suture anchor can occur if insertion sites are not prepared with appropriate instrumentation prior to implantation.Complaint history review indicated similar allegations for the lot number reported.Batch review indicated no condition, product or procedure failure that supported the allegation.Instructions for use contain recommendations and precautionary statements for proper use of product.Risk management files contain the reported failure.Various quality checks are in place to ensure that the material of the device meets requirements defined and validated in the design process.No indications from the devices show cause that the material was related to the reported failure.Product met specifications upon release to distribution.
Additional Manufacturer Narrative
H10.H3,h6: the reported 5.5 twinfix ultra pk anchor assembly, used in treatment, has not been returned for evaluation, however photographs were supplied.Examination of the photographs confirmed the reported complaint.The photo showed four devices, all of which show four device anchors broken at the suture eyelet.From the information provided, the anchors broke during insertion.An exact root cause cannot be determined with confidence with the limited clinical information provided; 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 outlines 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: TWINFIX ULTRA PK 5.5MM W/3UB-WHT 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: 9826379
• Report Number: 1219602-2020-00516
• Device Sequence Number: 19600321
• Product Code: MBI
• UDI-Device Identifier: 03596010647481
• UDI-Public: 03596010647481
• Combination Product (Y/N): N
• Initial Reporter Country: TS
• PMA/510(K) Number: K093228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2020

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: 03/29/2024
• Device Model Number: 72202600
• Device Catalogue Number: 72202600
• Device Lot Number: 2030924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 04/14/2020; 09/01/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 04/15/2020; 09/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1