MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX TI 5.0 ULTRABRAID; STAPLE, FIXATION, BONE

Model Number 72200755

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Pain (1994); Loss of Range of Motion (2032); Foreign Body In Patient (2687)

Event Date 04/16/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that on (b)(6) 2021, during a right patellar fracture surgery, two "5.0mm twinfix, ti ultrabraid anchors" were used to fix the lower pole bone and reconstruct the patellar ligament.Later, on (b)(6) 2021, when the patient was exercising in rehab dept., the right knee joint made a strange noise, and the patient complained of knee joint pain and limited movement.On (b)(6) 2021, x-rays showed that the bone mass of the lower pole of the right patella was displaced.During the operation, it was found that the sutures of the two "5.0mm twinfix, ti ultrabraid anchors" were completely broken.Both anchors remain inside the patient, but the sutures were retrieved.Finally, the fracture was treated with internal fixation again using two "kirschner wires" on revision surgery.No delays nor further complications were reported.The patient discharged from the hospital and the knee function of the right lower limb recovered.

Manufacturer Narrative

H6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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 concluded this was a repeat issue.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 review of risk management files found that the reported failure was documented appropriately.A review of the print specifications found that the storage requirements, material specifications, and material tests were appropriately documented.A review of the complaint revealed that based on the x-ray report the right patella was displaced.However, x-rays were not provided and without the pre/post-implantation x-rays the root cause of the reported failure could not be determined.The patient's knee function was reported to have recovered and patient¿s impact beyond what has already been reported cannot be determined.No further clinical assessment is warranted.A relationship, if any, between the subject device and the reported event could not be determined.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.

• Brand Name: TWINFIX TI 5.0 ULTRABRAID
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11850456
• MDR Text Key: 251472150
• Report Number: 1219602-2021-01176
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 03596010577986
• UDI-Public: 03596010577986
• Combination Product (y/n): N
• PMA/PMN Number: K972326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72200755
• Device Catalogue Number: 72200755
• Device Lot Number: 2044760
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR