MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWNFX TI 3.5 STR ANCHR W/2 ULTRB STR N; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	7210707
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was informed that during an humerus osteosynthesis procedure, at the end of the procedure, the specialist informed the twinfix anchor broke when it was placed in the corresponding place.The anchor was checked and it was in perfect condition, it was not broken or fractured.Then, the specialist informed that the screw was in good condition, but he indicated that the sutures came loose from the screw when they were in the anchor, it was checked and indeed the sutures were disassembled.The anchor was removed from the patient.The procedure was completed using a competitor device.It is unknown if there was a surgical delay, and no further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was informed that during an humerus osteosynthesis procedure, at the end of the procedure, the specialist informed the twinfix anchor broke when it was placed in the corresponding place.The anchor was checked and it was in perfect condition, it was not broken or fractured.Then, the specialist informed that the screw was in good condition, but he indicated that the sutures came loose from the screw when they were in the anchor, it was checked and indeed the sutures were disassembled.The anchor was removed from the patient.The procedure was successfully completed with a non-significant surgical delay using a back-up device.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H2: correction in h6 (health effect - impact code).
Event or Problem Description
It was informed that during an humerus osteosynthesis procedure, at the end of the procedure, the specialist informed the twinfix anchor broke when it was placed in the corresponding place.The anchor was checked and it was in perfect condition, it was not broken or fractured.Then, the specialist informed that the screw was in good condition, but he indicated that the sutures came loose from the screw when they were in the anchor, it was checked and indeed the sutures were disassembled.The anchor was removed from the patient.The procedure was successfully completed without surgical delay using a back-up device.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H2: additional information in b5.Correction in h6 (health effect - impact code).
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.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.A review of the titanium found that no burrs, cracks, or contamination is allowed.A certification of compliance to material and processing specifications is required.A visual inspection of the returned device found that it is not in its original packaging.The anchor is deformed and gouged at the proximal end, there were no suture materials returned.The handle of the insertion device is broken in half.Both the insertion device and the anchor have debris on them.Based on the condition of the product material found during visual inspection, additional material testing is not required.A review of the customer provided images finds the anchor of the complaint device with the proximal end deformed.No insertion device or suture material is shown.Since it was reported that the patient¿s health was not affected, no further clinical/medical 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: TWNFX TI 3.5 STR ANCHR W/2 ULTRB STR N
• 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: 15658733
• Report Number: 1219602-2022-01605
• Device Sequence Number: 12191545
• Product Code: MBI
• UDI-Device Identifier: 03596010532190
• UDI-Public: 03596010532190
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K972326
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/19/2023

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 Expiration Date: 10/02/2026
• Device Model Number: 7210707
• Device Catalogue Number: 7210707
• Device Lot Number: 2080515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2022
• Supplement Date Received by Manufacturer: 10/28/2022; 11/04/2022; 01/19/2023
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 10/31/2022; 11/04/2022; 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2021
• 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: 14 YR
• Patient Sex: Male