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

Catalog Number 72205135

Device Problem Break (1069)

Patient Problems Rupture (2208); Unspecified Tissue Injury (4559)

Event Date 07/04/2022

Event Type  Injury  

Event Description

It was reported that during a knee procedure using helicoil anchor, the proximal screw of anchor did not advance into the tibial bone, it ended up snapping.The broken pieces were retrieved from the patient with gillies forceps.A void was left in the patient.The procedure was completed with a non-significant surgical delay using a swivelok 4.75 pk competitor's device in an additional bone hole.No further complications were reported.The patient current status is fine.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H10: h3, 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.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 complaint history review found similar reported events.A review of the material drawing found material to comply with specifications by testing the percentage of composition.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.The provided pilgrim form supports the case.Without supporting clinical documentation, a thorough medical investigation could not be rendered, nor could the definitive root cause of the reported failure be determined.Based on the information provided, the broken pieces were retrieved from inside of the patient with gillies forceps.It was reported the surgeon completed the procedure using a competitor¿s device in an additional bone hole with a non-significant surgical delay leaving a void in the patient.According to the report, there were no other complications reported, and the patient¿s status has been reported as ¿fine¿.Therefore, since there has been no harm alleged to this patient, no further clinical/medical assessment is warranted at this time.Should any additional relevant medical information be provided, this case would be re-assessed.There was no relationship found between the device and the reported event.The complaint was not confirmed.Factors that may have contributed to the reported event include not maintaining inserter alignment throughout insertion to ensure implant integrity.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

H11: corrected data h6 (health effect - clinical code and health effect - impact code).

• Brand Name: HEALICOIL KNOTLESS RGNST
• 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: 15121983
• MDR Text Key: 296778077
• Report Number: 1219602-2022-01071
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885556767146
• UDI-Public: 885556767146
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K193558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/31/2022

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 Catalogue Number: 72205135
• Device Lot Number: 51011295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2022
• Initial Date FDA Received: 07/28/2022
• Supplement Dates Manufacturer Received: 08/24/2022; 08/26/2022
• Supplement Dates FDA Received: 08/26/2022; 08/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2022
• 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): Other; Required Intervention