MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ULTRA FAST-FIX AB ASSEMBLY - CURVED; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number 72201494

Device Problem Mechanical Problem (1384)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2023

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that during an arthroscopy, after the t2 of the ultra fast-fix was implanted, it could not be withdrawn.In consequence, the t2 had to be removed with tweezers.The procedure was completed without significant surgical delay using a s+n back-up device.No further complications were reported.

Manufacturer Narrative

Internal complaint reference: (b)(4).B5 and h6: event description, clinical and health codes updated.

Event Description

It was reported that during an arthroscopy, after the t2 of the ultra fast-fix was implanted, it was hard to remove the inserter.In consequence, the t2 had to be removed with tweezers and t1 was left secured in the patient.The procedure was completed without significant surgical delay using a s+n back-up device.No further complications were reported.

Manufacturer Narrative

H10: h3, h6:the reported device was received for evaluation.A visual inspection revealed the device was returned in original packaging with the batch number of the complaint on the label.The t1 and suture were returned off the needle.The t2 has been cut from the suture and not returned.The knot has not been tightened down.The variable depth straw has not been trimmed.A functional evaluation could not be performed since both implants have already been deployed.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 no similar reported events.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 root cause could not be determined since the reported malfunction could not be duplicated during the investigation.Factors that can contribute to the reported event include improper deployment technique for t2.No containment or corrective actions are recommended at this time.

• Brand Name: ULTRA FAST-FIX AB ASSEMBLY - CURVED
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• 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: 17926931
• MDR Text Key: 325590418
• Report Number: 1219602-2023-01971
• Device Sequence Number: 1
• Product Code: GAT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K151105
• 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: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72201494
• Device Lot Number: 2075919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2021
• 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