MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX 2.8 TI W/NDL 22-0 ULTRABRAID; STAPLE, FIXATION, BONE

Model Number	72202067
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an arthroscopy, the specialist was placing the twinfix, he pulled the ultrabraid strands that come out of the anchor and pulled it so hard that he pulled out the anchor completely, a second twinfix of the same lot number was used and the same thing happened because it impacted the anchor too hard and pulled the strands with enough force.He was informed about the placement of the anchor but he ignored the procedure and ended up doing some stitches with the same ultrabraid strands of the anchors.There was no delay reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H2: additional information: h6: health effect - impact code.H3, h6: the reported device was received for evaluation.A visual inspection revealed the device is not in its original packaging.Device 1 was returned with no anchor, needles or suture material.Device 2 was returned with the anchor and needles attached to the sutures.There is debris on all returned items.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.The instructions for use were 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.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.Factors that can contribute to the reported event include inadequate bone quality, improper preparation of the insertion site, or off-axis insertion of the device.No containment or corrective actions are recommended at this time.

• Brand Name: TWINFIX 2.8 TI W/NDL 22-0 ULTRABRAID
• Common Device Name: STAPLE, FIXATION, BONE
• 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: 16440966
• Report Number: 1219602-2023-00247
• Device Sequence Number: 16943539
• Product Code: JDR
• UDI-Device Identifier: 03596010619112
• UDI-Public: 03596010619112
• 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
• Report Date (Section B): 07/25/2023

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 Model Number: 72202067
• Device Catalogue Number: 72202067
• Device Lot Number: 2086815
• 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: 02/02/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 02/25/2023
• Supplement Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female