MAUDE Adverse Event Report: SMITH & NEPHEW, INC. AIMER TIBIAL PCL; ACCESSORIES,ARTHROSCOPIC

Catalog Number 7207282

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/28/2019

Event Type  malfunction  

Event Description

It was reported a rust on the director pcl tibial.No patient injuries or delay reported as the failure was found after the surgery.

Manufacturer Narrative

One 7207282 pcl tibial aimer returned.The complaint stated: ¿rust on the director.¿ the product displays permanent water marks and staining.Low-sudsing, neutral 6.0¿8.0 ph, enzymatic detergents are recommended.Do not use detergents above 11.0 ph.Use deionized water for washing and rinsing.There are no other complaints for this lot.This is considered an isolated instance.Determined efforts are made to control all processes prior to release.At this time there are no other complaints for this manufacturing lot.This is considered an isolated instance.Additional information received by the customer stated that the rust device was not used on patients.

• Brand Name: AIMER TIBIAL PCL
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8497396
• MDR Text Key: 141457138
• Report Number: 1219602-2019-00403
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010388230
• UDI-Public: 03596010388230
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/16/2019

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 Catalogue Number: 7207282
• Device Lot Number: 50732282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 04/09/2019
• Supplement Dates Manufacturer Received: 05/15/2019
• Supplement Dates FDA Received: 05/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1