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

Model Number 72202901

Device Problems Difficult to Insert (1316); Device Dislodged or Dislocated (2923)

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

Event Date 10/29/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that during an arthroscopy procedure, the ultra pk suture anchor was used to fix the passed threads at the root of the meniscus.An incision was made at the proximal level of the tibia, the tunnel is made with the 4.5mm drill and the threads are recovered; distal to that tunnel, a hole was dissected and a hole was made for the anchor with a 3.8mm awl of the equipment, the threads were passed through the anchor eyelet and it was positioned in the previously made hole, the tension of the threads was verified and impact the implant, it was verified that it had been well impacted, the retention thread was removed and the anchorage was blocked by turning the orange knob to the right, at this moment it was evident that the device did not make the "click" sound that indicates a correct locking was attempted several times by turning the knob but never locking the anchor and the threads came out of the implant.This anchor was removed and another of the same reference should have been used.The procedure was successfully completed with non-significant delay using a back-up device.No patient complications were reported.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no way to determine if the device contributed to the reported event.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.The complaint was not confirmed.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an 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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

Manufacturer Narrative

H10:internal complaint reference: case-(b)(4).H3, h6: part of the reported device was received for evaluation.There was no way to determine if the device contributed to the reported event.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 visual inspection of the returned device found that it is not in its original packaging.The anchor and sutures were not returned.There is debris on the device.No deficiencies can be seen.Based on the condition of the product material found during visual inspection, additional material testing is not required.A functional evaluation of the device found that the torque limiter functioned as intended.Three audible clicks were heard when the device was tightened.The complaint was not confirmed, and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an 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: 12847381
• MDR Text Key: 281134632
• Report Number: 1219602-2021-02546
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010650528
• UDI-Public: 03596010650528
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• 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: 2067841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2021
• 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 Sex: Female