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

Model Number 72202901

Device Problem Unsealed Device Packaging (1444)

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

Event Date 09/02/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during shoulder rotator cuff repair surgery, when opened the footprint ultra pk suture anchor 4.5 it was found air leakage.The procedure was finished with a smith and nephew backup device.No surgical delay.Patient injuries were not reported.

Manufacturer Narrative

H3, h6: the reported device, intended for use 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.A review of the pouch specifications found that the pouches must be free of nicked edges, must be clean and free of foreign material to a certain size.A material certification is required for each lot.A visual inspection of the returned device found that the device is unopened in its packaging.There is air in the packaging.The packaging is heavily crumpled.The seals are unbroken, but there is a small tear on the paper side of the packaging approximately 3.2mm in length following the direction of the wrinkles of the bag.The complaint was confirmed but the root cause cannot be established.Factors that could have contributed to the reported event include inadvertent excessive force to the package or rough handling of the package.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.

Manufacturer Narrative

Internal complaint reference case-(b)(4).The reported device, intended for use 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.A review of the pouch specifications found that the pouches must be free of nicked edges, must be clean and free of foreign material to a certain size.A material certification is required for each lot.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 visual inspection of the returned device found that the device is unopened in its packaging.There is air in the packaging.The packaging is heavily crumpled.The seals are unbroken, but there is a small tear on the paper side of the packaging approximately 3.2mm in length following the direction of the wrinkles of the bag.The complaint was confirmed and the root cause was associated with the product design.Factors that could have contributed to the reported event include inadvertent excessive force to the package damage in transit.A corrective action was implemented to mitigate recurrence of the reported event and a field action was initiated to recall the product.

• 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: 12516411
• MDR Text Key: 272889425
• Report Number: 1219602-2021-02116
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2023
• Device Model Number: 72202901
• Device Catalogue Number: 72202901
• Device Lot Number: 50735323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2018
• 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 Sex: Male
• Patient Weight: 66 KG