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

Model Number 72202901

Device Problem Fracture (1260)

Patient Problems Foreign Body In Patient (2687); Unspecified Tissue Injury (4559)

Event Date 04/08/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during use in a shoulder cuff repair surgery, the footprint anchor was fractured.The anchor was not removed, it remained inside the patient.A void was left.The procedure was completed with non-significant surgical delay and was finished with a smith and nephew back up device in an additional bone hole.No other patient complications were reported.The current status of the patient is good.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.It was determined the device contributed to the reported event.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 was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the polymer found that tensile strength and impact strength are specified and each batch of raw material must be accompanied by a certificate of analysis detailing the exact composition of the batch.A review of the customer provided image found a picture of the device, outside the original packaging with a fractured anchor laying near the insertion device.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.The distal tip of the insertion device is slightly bent and has debris on it.The fractured anchor also has debris on it.No sutures were returned.Based on the condition of the product material found during visual inspection, additional material testing is not required.This case reports, the anchor fractured during a shoulder cuff repair surgery.Reportedly, the anchor was not removed and remained inside the patient.Per correspondence, the procedure was completed with a smith and nephew backup device in an additional bone hole.A void was left in the patient.No additional patient complications were reported.No additional information was provided.The complaint was confirmed, and 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, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event inconsistent with normal use.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.

• 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: 14249972
• MDR Text Key: 290373799
• Report Number: 1219602-2022-00611
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/07/2022

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: 2069049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/08/2022
• Initial Date FDA Received: 04/29/2022
• Supplement Dates Manufacturer Received: 06/03/2022
• Supplement Dates FDA Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2021
• 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): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 58 KG