MAUDE Adverse Event Report: SMITH & NEPHEW, INC. AIMER ENDOFEMORAL 5MM OFFSET (RED); ACCESSORIES,ARTHROSCOPIC

Model Number 72201715

Device Problems Crack (1135); Flaked (1246)

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

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during an acl reconstruction, when the passing pin was passed through the endofemoral aimer, a significant amount of swarf came off.On inspection, it was noticed that the aimer had a small groove at the distal tip.All the material was removed using suction from shaver and a lavage of the knee was performed.The procedure was successfully completed without a significant delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported endo-femoral aimer, used in treatment, has been returned for evaluation.Visual assessment of the device showed a burr has developed on the distal end of the aimers cannulation.This indicates that the guidewires or passing pins used in conjunction with the aimer came in contact with the damaged surface causing the reported shedding.Per the device ifu: under precautions ¿prior to use, inspect the device to ensure it is not damaged.Do not use a damaged device¿.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.Further investigation is not warranted at this time.

• Brand Name: AIMER ENDOFEMORAL 5MM OFFSET (RED)
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9519955
• MDR Text Key: 173298486
• Report Number: 1219602-2019-01630
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010608208
• UDI-Public: 03596010608208
• 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: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72201715
• Device Catalogue Number: 72201715
• Device Lot Number: 50652610
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1