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 Device Contamination with Chemical or Other Material (2944)

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

Event Date 06/18/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during arthroscopy procedure, inside the patient, when the healicoil sa pk 4.5mm w/2 ub-bl cbrd bl was inserted into the joint, a hair was clearly visible in the anchor.Anchor was immediately removed from the joint, part of it is still hanging in the anchor, part of the hair had to be removed with the help of suture grasping forceps.The device was inspected before use but it is unknown if the hair was noticed or not.The procedure was finished with a smith and nephew backup device.Surgical delay less than or equal to 30 minutes.Patient injuries were not reported.

Manufacturer Narrative

The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A review of the customer provided image shows what could be a hair in the surgical field.The anchor is not shown in relation to the apparent hair.A visual inspection revealed the device was returned outside of original packaging.The carton contained opened unsealed packaging.The device was not actuated and the anchor was still attached to the shaft.The device had debris, but showed no hair attached to the anchor.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 review of risk management files found that the reported failure was documented appropriately.A review of the drawing found the device packaging must be free of particulates, debris, and hair.The complaint was confirmed, but the root cause could not be determined due to the state the device was returned in.Factors that would have contributed to the reported failure include compromised sterility.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
• MDR Report Key: 12129773
• MDR Text Key: 260310252
• Report Number: 1219602-2021-01514
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010657862
• UDI-Public: 03596010657862
• Combination Product (y/n): N
• PMA/PMN Number: K113294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• 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: 2065798
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention