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

Catalog Number	7207282
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2019
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8497396
• Report Number: 1219602-2019-00403
• Device Sequence Number: 2515820
• Product Code: NBH
• UDI-Device Identifier: 03596010388230
• UDI-Public: 03596010388230
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 04/09/2019
• Supplement Report FDA Received Date: 05/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1