MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FOOTPRINT ULTRA PK SUTURE ANCHOR 5.5; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72202902

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during shoulder cuff repair surgery, the footprint suture anchor pulled out.The procedure was completed with a back-up device.It is unknown if there was a delay.No further complications were reported.

Manufacturer Narrative

H11: corrected information in h6 (health effect - impact code).

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The insertion device and a fractured anchor were returned with no suture material.The anchor is fractured at the suture window and the fins at the proximal end are deformed.There is debris on all returned items.Based on the condition of the product material found during visual inspection, additional material testing is not required.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 material specifications found the raw material strength and storage requirements specified and each lot be must be accompanied by a material certificate of analysis.A clinical review states one undated image of the device was provided for review and display the anchor with a missing tip.It is unknown if the tip was retrieved from the patient.Based on the information provided no clinical factors were found which would have contributed to the reported breakage.The footprint suture anchor is implantable, biocompatibility is not an issue.If retained micro-motion or movement cannot be predicted.There is potential risk for tissue inflammation and/or pain.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, or an inadvertent impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.

• Brand Name: FOOTPRINT ULTRA PK SUTURE ANCHOR 5.5
• Type of Device: 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: 16018084
• MDR Text Key: 305843278
• Report Number: 1219602-2022-02013
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K093897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72202902
• Device Catalogue Number: 72202902
• Device Lot Number: 2073012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other