MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REFURB AIMER ENDFMRL 6MM OFFSET (GREEN); ACCESSORIES,ARTHROSCOPIC

Catalog Number 72201716F

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 01/20/2018

Event Type  malfunction  

Event Description

It was reported that after drilling femoral pin with the aid of the 6mm femoral guide, surgeon was pulling the aimer out of the knee.Upon pulling, the distal end of the aimer broke off from the rest of the arm and for a short time remained inside the patients knee.No patient injury was reported.

Manufacturer Narrative

Information received by the manufacturer revealed and was verified that this reportable event 1219602-2018-00211 is a duplicate submission of 1219602-2018-00059.Please disregard the submission of 1219602-2018-00211.

• Brand Name: REFURB AIMER ENDFMRL 6MM OFFSET (GREEN)
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7266537
• MDR Text Key: 100062624
• Report Number: 1219602-2018-00211
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2018

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: 72201716F
• Device Lot Number: 50305400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2018
• Initial Date FDA Received: 02/13/2018
• Supplement Dates Manufacturer Received: 03/05/2018
• Supplement Dates FDA Received: 03/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1