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

Catalog Number 72201717

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

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

Event Date 09/07/2016

Event Type  malfunction  

Event Description

It was reported during an acl reconstruction procedure that the endofemoral aimer broke in the patient.The broken piece was removed from the patient with a grasper.A backup device was inserted into the same bone hole to complete the procedure.No patient injury or complications were reported.

Manufacturer Narrative

Endofemoral aimer tip may separate due to failure of the soldered joint from use.This aimer has been in service for an extended period of time and is known to have the joint separate due to wear and tear.This design is no longer available and has been updated to prevent this type of failure.Device history record review found there were no deficiencies with this lot when released to distribution.

• 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: james gonzales ; 7000 w william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 5973037
• MDR Text Key: 55702130
• Report Number: 1219602-2016-00930
• 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: company representative,user f
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/08/2016

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: 72201717
• Device Lot Number: 50270510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2016
• Initial Date FDA Received: 09/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/16/2016
• 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
• Patient Age: 40 YR