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

Catalog Number	72202610
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	04/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in the original packaging.The anchor is fractured below the proximal end of the suture window, the anchor and suture strings are on the insertion device.The prongs at the distal end of the insertion shaft are deformed and there is biological debris on the returned item.Based on the condition of the product material found during visual inspection, additional material testing is not required.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.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.A review of the material specifications found that the storage requirements for the material are specified, and the material must comply with provided percentage composition specifications as measured by ash test.A clinical review states that there is a definitive clinical route cause.Based solely on the results of the product evaluation the root cause of the reported issue was the result of a user vs procedural variance.The device instruction for use does caution that ¿use of excessive force during insertion can cause failure of the suture anchor or insertion device.¿ no further risk to the patient is anticipated as a result of the additional bone hole.The root cause has been associated with unintended use of the device.Factors that could have contributed to the failure include an application of unintended inappropriate or excessive force to the device.Based on this investigation, the need for corrective action is not indicated.
Event or Problem Description
It was reported that during a shoulder arthroscopy with rc repair, the surgeon tried to screw in the anchor after preparing the site with the twinfix spade tip drill.During the insertion, the anchor of the twinfix ultra broke.The bone had normal quality.The anchor was retrieved out of the patient with a grasper.The procedure was successfully completed with a delay of less than 30 minutes using a smith and nephew back up device.An additional hole was drilled for the back up device.There was a void left in the patient.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).

• Brand Name: TWINFIX ULTRA PLLA/HA 6.5 W/3 UB
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, 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: 19243624
• Report Number: 1219602-2024-00932
• Device Sequence Number: 7439804
• Product Code: MAI
• UDI-Device Identifier: 03596010647627
• UDI-Public: 03596010647627
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K151105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2024

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: 72202610
• Device Lot Number: 2123147
• 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: 04/11/2024
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 07/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2023
• 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: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Male