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

Model Number 72202901

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Date 10/28/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case-(b)(4).

Event Description

It was reported that, during shoulder rotator cuff repair surgery using footprint ultra pk suture anchor, was found fractured, all broken pieces were extracted from the patient using tweezers.The malfunction was solved with a delay shorter than 30 minutes and no patient harm using a back up device.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: part of the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A complaint history review concluded this was a repeat issue.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 review of risk management files found that the reported failure was documented appropriately.A review of the polymer found that the storage requirements, material specifications, and applicable tests were appropriately specified.A material certificate of analysis was required for the raw material.A review of the customer provided image found two deployed devices next to a bag with two pieces of fractured anchor inside.A visual inspection of the returned device found that it is not in its original packaging.The anchor was not returned with the device.The distal end of the inserter is bent, and there is debris on the device.Based on the condition of the product material found during visual inspection, additional material testing is not required.The complaint was confirmed.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.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.

Event Description

It was reported that, during shoulder rotator cuff repair surgery using footprint ultra pk suture anchor, two anchors were found fractured, all broken pieces were extracted from the patient using tweezers.The malfunction was solved with a delay shorter than 30 minutes using a back up device.No further complications were reported.

• 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: 10864212
• MDR Text Key: 217087446
• Report Number: 1219602-2020-01863
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010650528
• UDI-Public: 03596010650528
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• 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: 50846822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2019
• 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): Required Intervention; Other
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 80 KG