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

Catalog Number 72205138

Device Problems Break (1069); Material Deformation (2976)

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

Event Date 06/16/2023

Event Type  malfunction  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that during an arthroscopy, the healicoil anchor broke when it was introduced into the bone.The procedure was completed without surgical delay using a back-up device.No further complications were reported.

Manufacturer Narrative

H10: internal complaint reference (b)(4).

Manufacturer Narrative

H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.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 review of the material specifications found that tensile strength requirements are specified.A material certificate of analysis (coa) is required for raw material.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 (b)(4).

Manufacturer Narrative

H10: h3, h6: the reported device was received for evaluation.A visual evaluation showed the device was not returned in any original packaging.There is a non-s&n barcode label on the body of the device which reads, "(b)(4)".The distal anchor was not returned.The distal plug is still in the insertion tube.The insertion tube is bent, split and deformed on the end.The proximal anchor is broken and missing some ribs.There are no other visible deficiencies.A functional evaluation showed the black knob and orange knob will only partially turn due to the bend in the tube.Based on the condition of the product material found during visual inspection, additional material testing is not required.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.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 review of the material specifications found that tensile strength requirements are specified.A material certificate of analysis (coa) is required for raw material.The root cause has been associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force upon insertion, or off-axial insertion.No containment or corrective actions are recommended at this time.

• Brand Name: HEALICOIL KNOTLESS PK ST
• 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: 17278830
• MDR Text Key: 319060336
• Report Number: 1219602-2023-01083
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885556767351
• UDI-Public: 885556767351
• Combination Product (y/n): N
• Reporter Country Code: KE
• PMA/PMN Number: K193558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2024
• Device Catalogue Number: 72205138
• Device Lot Number: 50935539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2021
• 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