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

Catalog Number 72201716

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

Patient Problem Foreign Body In Patient (2687)

Event Date 12/20/2017

Event Type  malfunction  

Event Description

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.

Manufacturer Narrative

Device has not been returned for evaluation.A root cause investigation was opened to investigate this failure mode.As a result a design change was implemented, modifying the offset endo femoral aimer arms to change the assembly method of the tips to the shaft from solder to laser welding.

• Brand Name: AIMER ENDOFEMORAL 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: 7182259
• MDR Text Key: 97064236
• Report Number: 1219602-2018-00059
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2018

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: 72201716
• Device Lot Number: 50305400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2017
• Initial Date FDA Received: 01/11/2018
• Supplement Dates Manufacturer Received: 02/26/2018
• Supplement Dates FDA Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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