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

Model Number 014796

Device Problems Bent (1059); Break (1069)

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

Event Date 07/04/2017

Event Type  malfunction  

Event 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.

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.

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)
• 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; building 1; austin, TX 78735
• MDR Report Key: 6750985
• MDR Text Key: 81475595
• Report Number: 1219602-2017-00824
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010026316
• UDI-Public: (01)03596010026316(10)50522116
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2017
• Initial Date FDA Received: 07/28/2017
• Supplement Dates Manufacturer Received: 08/29/2017; 02/12/2018
• Supplement Dates FDA Received: 08/30/2017; 02/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 26 YR