MAUDE Adverse Event Report: SMITH & NEPHEW, INC. AIMER ENDOFEMORAL 7MM OFFSET (GOLD); ACCESSORIES,ARTHROSCOPIC

Catalog Number	72201717
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 that the aimer was rust.No patient injuries or delay were reported as the failure was found after the surgery.
Additional Manufacturer Narrative
One 72201717 7mm offset endofemoral aimer returned.The complaint stated: ¿aimer was rust.¿ the product displays water marks and permanent staining.For instructions on automatic and manual sterilization recommendations.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.Allegation occurrence rate is monitored via surveillance.

• Brand Name: AIMER ENDOFEMORAL 7MM OFFSET (GOLD)
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8476021
• Report Number: 1219602-2019-00379
• Device Sequence Number: 1633954
• Product Code: NBH
• UDI-Device Identifier: 03596010608222
• UDI-Public: 03596010608222
• 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): 06/18/2019

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: 72201717
• Device Lot Number: 50745882
• 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: 06/17/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1