MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL SA PK 4.5MM W/2 UB-BL CBRD BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72203378

Device Problems Material Deformation (2976); Positioning Problem (3009)

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

Event Date 03/17/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that during use in a shoulder cuff repair surgery, the 'healicoil' anchor was loosen and bent, it was unable to be implanted.The procedure was completed with a s+n back-up device.An additional hole was necessary.Non-significant delay was reported, and no patient complications were reported.

Manufacturer Narrative

Correction in b5.

Event Description

It was reported that during use in a shoulder cuff repair surgery, the 'healicoil' anchor was loosen and bent, it was unable to be implanted.Bone quality was normal.The procedure was completed with a s+n back-up device.An additional hole was necessary.This resulted in a non-significant delay.No further complications were reported and the current status of the patient is good.

Manufacturer Narrative

Internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A complaint history review found no similar reported events.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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A visual inspection showed the product came in with the anchor and both sutures out of the inserter.The threads of the anchor are intact.The overall anchor is bent.The inserter fork is slightly bent.No further risk to the patient is anticipated as a result of the additional bone hole.Since no further harm is anticipated no further clinical assessment is warranted at this time.The complaint was confirmed, and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force on the device, attempted correction of a damaged device, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event inconsistent with normal use.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 SA PK 4.5MM W/2 UB-BL CBRD BL
• 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: 13996220
• MDR Text Key: 288500051
• Report Number: 1219602-2022-00493
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010657862
• UDI-Public: 03596010657862
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K113294
• 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,Followup
• Report Date: 03/30/2023

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 Model Number: 72203378
• Device Catalogue Number: 72203378
• Device Lot Number: 2067892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/21/2022
• Initial Date FDA Received: 04/04/2022
• Supplement Dates Manufacturer Received: 05/08/2022; 03/29/2023
• Supplement Dates FDA Received: 05/11/2022; 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2021
• 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