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	Break (1069)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	09/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a rotator cuff repair, two (2) twinfix ultra inserters broke when screwing-in the anchors.The broken pieces were removed with a grasper.The procedure was completed with a smith and nephew back up device with non significant surgical delay.A void was left in the patient.No further complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported devices were received for evaluation.There was a relationship found between the device and the reported event.A visual inspection of the returned devices found that they are not in their original packaging.Three insertion devices and anchors with suture strings were received with biological debris on all returned items.Device 1: the insertion device was returned with the distal end of the shaft fractured away.There is no anchor on the insertion device.Device 2: the insertion device was returned with the anchor in place, the suture strings still in the channel of the device.Device 3: the insertion device was returned without an anchor attached.There is no damage to the insertion device.There were 2 anchors returned off the insertion device.Anchor 1 has both suture strings through the suture window.Anchor 2 has only the blue/white suture string through the suture window, the white suture string was not returned.A complaint history review found similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.No further risk to the patient is anticipated as a result of the additional bone hole.Since no further harm is anticipated no further clinical assessment is warranted at this time.The complaint was confirmed, and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device, attempted correction of a damaged device, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event inconsistent with normal use.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

• 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 blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 17941681
• Report Number: 1219602-2023-01987
• Device Sequence Number: 12458206
• Product Code: MBI
• UDI-Device Identifier: 03596010652324
• UDI-Public: 03596010652324
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K152566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 72202900
• Device Lot Number: 2104390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: 01/05/2024
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown