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 Fracture (1260); Mechanical Jam (2983)

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

Event Date 11/01/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during a shoulder cuff repair surgery the healicoil top anchor was fractured and the suture was stuck when the package was opened.The procedure was completed without significant delay using a smith and nephew back up device.No further complications were reported.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).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 received in the original packaging with the batch number of the complaint on the label.The sutures are still in place on the inserter, through the cannula, and tied off on the handle.The anchor is intact, no sign of damage.The anchor has been moved forward to the tip of the inserter.A functional evaluation showed that the anchor and sutures move as intended.Based on the condition of the product material found during visual inspection, additional material testing is not required.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 similar reported events.A review of the anchor material drawing/specifications found that certifications and testing data are required for raw material.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 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: 15859951
• MDR Text Key: 304304447
• Report Number: 1219602-2022-01804
• 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,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72203378
• Device Catalogue Number: 72203378
• Device Lot Number: 2082567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2023
• Initial Date FDA Received: 11/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2021
• 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