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

Catalog Number 72205135

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/10/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during a rotator cuff repair, the surgeon was inserting a healicoil knotless anchor as the lateral row in a double row rotator cuff repair.The surgeon loaded 4 arthrex fibretapes through the eyelet successfully and inserted the anchor into the prepared hole.The surgeon tensioned the tapes to desired amount and punched the anchor into the hole until the threads engaged in the cortex.After descending the internal plug the surgeon attempted to descend the anchor, during this process it was noticed that the tip of the anchor had snapped off the inserter device.The inserter was withdrawn from the patient and graspers were used to remove the tip/eyelet from the patient, and the surgeon detached it from the tapes using nibblers.The surgery was resumed, after a non-significant delay, using an arthrex swivelock anchor in the same bone hole.No further complications were reported.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H3, h6: a device deficiency was identified, however the root cause of the reported event could not be determined since the device was not returned for evaluation.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.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.A review of the material specifications found that the raw material strength requirements and storage requirements specified and each lot be must be accompanied by a material certificate of analysis.An analysis of the customer provided image found a partial view of the device lying on a surgical mat.The proximal body can be seen on its distal end.There is no visible damage to the proximal body.The anchor plug and distal tip are missing from the device.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.

• 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: 15928923
• MDR Text Key: 304952975
• Report Number: 1219602-2022-01906
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• 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: 51039886
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2022
• 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): Required Intervention