MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL KNOTLESS PK NST; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number 72205137

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 02/25/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that during surgery, the healicoil knotless anchor was taken out when tightening the threads, it did not hold.A backup device was available to complete the procedure with no significant delay or other complications.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Event Description

It was reported that during surgery, the healicoil knotless anchor was taken out when tightening the threads, it did not hold.All the broken parts were removed from the patient using tweezers.A backup device was available to complete the procedure with no significant delay or other complications.

Manufacturer Narrative

H10: h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.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 complaint revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.A relationship, if any, between the subject device and the reported event could not be determined.No containment or corrective actions are recommended at this time.

Manufacturer Narrative

Part of the reported device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as pre-cautions 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 complaint revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.A visual inspection revealed the device was returned outside of original packaging.The anchor was not returned with the device.The device is coated in debris.The actuator appears to have been actuated.No visible damage to the device.A functional evaluation revealed the device actuators function as intended.The complaint was not confirmed and the root cause could not be determined as the condition in which the device was received did not allow for evaluation of the reported complaint.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: HEALICOIL KNOTLESS PK NST
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11633213
• MDR Text Key: 244377337
• Report Number: 1219602-2021-00809
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00885556767337
• UDI-Public: 00885556767337
• Combination Product (y/n): N
• PMA/PMN Number: K193558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2023
• Device Model Number: 72205137
• Device Catalogue Number: 72205137
• Device Lot Number: 50905821
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR