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 Problem Corroded (1131)

Patient Problem No Information (3190)

Event Date 10/13/2020

Event Type  Injury  

Event Description

It was reported that during shoulder rotator cuff repair surgery, the inserter matched with anchor were found rust.The device was used on the patient.A backup device was available to complete the procedure with no significant delay or other complications.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: h3, h6: the reported device was received for evaluation.An analysis of the customer provided images revealed orange discoloration along the laser markings of the device.A visual inspection revealed that the anchor had been deployed from the device.The anchor was not returned.There was some debris on the device from use, but there was also orange discoloration along all of the laser markings that did not rub off with a glove.It could not be determined if this was present on the device before use or if the material reacted to something in the surgical environment.A functional evaluation of the returned device is not applicable as a visual failure was reported.A complaint history review found 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 was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the procedure found that each component should be visually inspected for all non-conforming attributes defined in the procedure.It was determined the device contributed to the reported event.The complaint was confirmed and the root cause associated with the design of the device.A passivation layer was added to the shaft of future devices in order to prevent recurrence of this event.The biocompatibility of the color variation material is unknown, and the possibility of localized pain/discomfort, cannot be ruled out if the material or residue from the reported ¿rust¿ remains in the patient.This is presumed to be unlikely with intraoperative surgical awareness and standard irrigation of arthroscopic procedures but removal is not documented.No further medical assessment can be rendered at this time.A corrective action has been implemented to prevent future recurrence of this event.

• 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: 10808210
• MDR Text Key: 215257947
• Report Number: 1219602-2020-01800
• 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
• Report Date: 06/30/2022

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: 50823932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 06/28/2022
• Supplement Dates FDA Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Female
• Patient Weight: 60 KG