MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72202901

Device Problem Mechanical Jam (2983)

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

Event Date 03/02/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during a rotator cuff repair procedure, the footprint ultra suture anchor internal plug was not locking.The procedure was completed with a non-significant delay using a smith and nephew back-up device.No further complications were reported.

Manufacturer Narrative

H10: h2: additional information: d4: lot number and expiration date, h4: device manufacture date.

Manufacturer Narrative

Internal complaint reference: (b)(4).H10 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 was returned with the interior bar jammed back into the handle and no suture material or anchor.There is debris in the channel of the shaft.A review of the customer provided image finds an insertion device with the interior bar shorter than normal.A functional assessment of the returned device finds the interior shaft of the inserter is jammed into the handle.The anchor and suture string were not returned for testing.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 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 clinical review states the provided photo was reviewed but does not aid in determining a clinical root cause for the reported internal plug not locking.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, 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 4.5
• 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: 16611758
• MDR Text Key: 311956108
• Report Number: 1219602-2023-00414
• 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: 02/07/2024

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
• Device Operator: Health Professional
• Device Model Number: 72202901
• Device Catalogue Number: 72202901
• Device Lot Number: 2089545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/02/2023
• Initial Date FDA Received: 03/24/2023
• Supplement Dates Manufacturer Received: 08/15/2023; 02/06/2024
• Supplement Dates FDA Received: 08/23/2023; 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2022
• 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