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

Catalog Number 72205135

Device Problem Firing Problem (4011)

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

Event Date 07/21/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a rotator cuff repair procedure, the distal healicoil anchor could not come off from the shaft.The proximal anchor was flipped and removed from patient.The procedure was completed without significant delay (5 minutes) using a back-up device (healicoil ut5.5) in an additional bone hole.No patient injury or other complications were reported.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection revealed the device was not returned with original packaging and the device does have debris on it.Distal tip and anchor plug are detached from device.No other physical damage is visible to the device a functional evaluation of the returned device found that device is in pieces and could not be performed.A complaint history review concluded this was a repeat issue.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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 there was no way to determine if the device contributed to the reported event.The complaint was not confirmed, and the root cause could not be determined as the condition in which the device was received did not allow for evaluation of the reported complaint.Factors, which could have contributed to the complaint event, include an application of unintended or inappropriate or excessive force to 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 relevant supporting clinical information has been provided to assist with a clinical investigation.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.No containment or corrective actions are recommended at this time.

• Brand Name: HEALICOIL KNOTLESS RGNST
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, 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: 12303847
• MDR Text Key: 265972346
• Report Number: 1219602-2021-01694
• Device Sequence Number: 1
• Product Code: MAI
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2024
• Device Catalogue Number: 72205135
• Device Lot Number: 50920407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2021
• 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
• Patient Outcome(s): Required Intervention