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

Catalog Number 72205135

Device Problem Separation Failure (2547)

Patient Problems Rupture (2208); Device Embedded In Tissue or Plaque (3165)

Event Date 09/26/2022

Event Type  Injury  

Event Description

It was reported that during a rotator cuff repair procedure with healicoil anchor, only the distal anchor was deployed when the anchor was being inserted into the bone hole and the dial was turned.The distal anchor could not be removed from the patient.The procedure was completed with a non-significant surgical delay using a back-up device in an additional drilled bone hole.No further complications were reported.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

Internal complaint reference case(b)(4).H10: h3, h6: the reported device was received for evaluation.There was no relationship found between the device and the reported event.A visual evaluation of the device showed it was not returned in the original packaging.The distal anchor and distal plug are missing.The proximal body is still intact and in place.The number one knob is fully actuated for the actuator is be extended beyond the end of the inserter.A functional evaluation showed knob number one move forward and back as intended.Knob number two moves the proximal body forward as intended.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 no similar reported events.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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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 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: 15631885
• MDR Text Key: 301995885
• Report Number: 1219602-2022-01562
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885556767146
• UDI-Public: 885556767146
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• 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: 51048622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2022
• 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
• Patient Age: 67 YR
• Patient Sex: Female