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

Model Number 72205137

Device Problem Material Deformation (2976)

Patient Problem Rupture (2208)

Event Date 09/08/2022

Event Type  Injury  

Event Description

It was reported that during an arthroscopy procedure, two healicoil anchors stripped when used in hard bone, the first one was inserted into a hole made with a 3.8mm awl and after two turns, it shredded.The second anchor was then inserted in the same hole after using a 4.75mm awl/dilator to create a thread in the bone as the 3.8mm awl had not be efficient enough.Once again the anchor shredded at the solid/open architecture junction of the anchor.The procedure was successfully completed with a non-significant surgical delay using a back-up device in an additional bone hole.No further complications were reported.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

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.There was no relationship found between the device and the reported event.The complaint was not confirmed.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.A clinical review states that this case reports two failed placement attempts of the healicoil anchor.Per e-mail communication, the second and third anchors used were inserted using a 3.8mm awl and then a 4.75mm awl/dilator, both the anchors reportedly ¿shredded.¿ it was noted that the surgeon was able to remove the second anchor, however, the third anchor was locked in the bone and could not be removed.The final anchor was placed in the bone without complications.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.Based on the information provided user vs procedural variance cannot be ruled out a contributing factor to the reported events.The device instructions for use does caution that, ¿use of excessive force during insertion can cause failure of the suture anchor or insertion device¿ and ¿it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.¿ the healicoil anchor is implantable, biocompatibility is not an issue.Micro-motion or movement cannot be predicted.There is potential risk for tissue inflammation and/or pain.There is no expected impact to the patient as only a single new bone hole was made for a new anchor and no further complications were reported.No further clinical/medical assessment is warranted at this time.¿ 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 no similar reported events.The instructions for use were 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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.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.

• Brand Name: HEALICOIL KNOTLESS PK NST
• 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: 15658735
• MDR Text Key: 302272774
• Report Number: 1219602-2022-01606
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885556767337
• UDI-Public: 00885556767337
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72205137
• Device Catalogue Number: 72205137
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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