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

Catalog Number 72201717

Device Problem Device Inoperable (1663)

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

Event Date 09/29/2016

Event Type  malfunction  

Event Description

It was reported that the 7mm offset endofemoral aimer did not work during a cruciate ligament repair procedure.A backup was used to complete the procedure.A delay of less than 30 minutes was noted.No injury or complications were reported.

Manufacturer Narrative

Device not returned to manufacturer for evaluation.Examination was not possible, as the device was not returned.The investigation was limited to the information provided.The investigation could not draw any conclusions about the reported event with the clinical details provided.A review of the device history record was performed which confirmed no inconsistencies.No further investigation is warranted at this time.(b)(4).

• Brand Name: AIMER ENDOFEMORAL 7MM OFFSET (GOLD)
• 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 w william cannon dr.; austin, TX 78735 ; 5123585706
• MDR Report Key: 6053612
• MDR Text Key: 58301616
• Report Number: 1219602-2016-01205
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72201717
• Device Lot Number: 50536780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1