MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FF FLEX RVRS CRVD INSTR; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number 72205677

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 04/12/2023

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that during set up for a meniscus repair surgery, upon opening the box of the ff flex rvrs crvd instr the scrub nurse noticed the packaging was slightly peeled off at the corner.It was deemed unsterile and was not used.There was a back-up device available and no delay was reported.There was no patient involvement.

Manufacturer Narrative

H10: internal complaint reference (b)(4).H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications 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.A review of the material specifications found that the lidstock is visually inspected and must be free of nicked or frayed edges, embedded particulates, dust, foreign matter, burn marks, discolorations, splay and flow lines on surface.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: FF FLEX RVRS CRVD INSTR
• 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: 16855695
• MDR Text Key: 314411876
• Report Number: 1219602-2023-00626
• Device Sequence Number: 1
• Product Code: GAT
• UDI-Device Identifier: 00885556804711
• UDI-Public: 885556804711
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K203393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 72205677
• Device Lot Number: 2091812
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1