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

Model Number	014796
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/04/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure the tip of the guide bent.The physician tried to straighten the pointed end but broke it.All pieces were removed from the patient.A backup device was used to complete the procedure.
Additional Manufacturer Narrative
Due to no product being returned the complaint could not be confirmed.Evaluation and investigation are not possible.No definitive conclusions can be made without pertinent manufacturing information or a device to evaluate.No further actions can be taken at this time.A review of the device history record shows that this device passed all acceptance criteria and was compliant upon release for distribution.There are no indications to suggest the device did not meet product specifications nor does it allege any product deficiencies upon release into distribution.
Additional Manufacturer Narrative
One (b)(4) 6mm offset endofemoral aimer returned.This is a reusable instrument that is three years old.There was only one portion received.The customer¿s photo shows the broken tip portion.The shaft portion returned has a piece of surgical tape attached where the tip may have been, but is it not with the shaft any longer.The u slide channels have dents and material displaced from overtightening of the universal handle with the aimer.The tip break site is 0.065¿ thick.This indicates a moderate amount of force was used to bend/break this area.Excessive force can result in instrument failure.No root cause related to the manufacture of the device was established.Further investigation is not required at this time.

• Brand Name: AIMER ENDOFEMORAL 6MM OFFSET (GREEN)
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 6750985
• Report Number: 1219602-2017-00824
• Device Sequence Number: 18995947
• Product Code: NBH
• UDI-Device Identifier: 03596010026316
• UDI-Public: (01)03596010026316(10)50522116
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/15/2018

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
• Operator of Device: Health Professional
• Device Model Number: 014796
• Device Catalogue Number: 72201716
• Device Lot Number: 50522126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Initial Date Received by Manufacturer: 07/04/2017
• Supplement Date Received by Manufacturer: 08/29/2017; 02/12/2018
• Initial Report FDA Received Date: 07/28/2017
• Supplement Report FDA Received Date: 08/30/2017; 02/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR