MAUDE Adverse Event Report: SMITH & NEPHEW, INC. AIMER ENDOFEMORAL 5MM OFFSET (RED); ACCESSORIES, ARTHROSCOPIC

Catalog Number 72201715

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

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

Event Date 02/11/2016

Event Type  malfunction  

Manufacturer Narrative

Initial reporter foreign postal code: (b)(4).One 5mm offset endofemoral aimer was returned for evaluation.A visual inspection of the device confirmed the reported breakage.The aimer tip has broken off at the weldment.The aimer tip is bent.It appears that excessive force was placed on the tip causing it to break free from the shaft.Dimensional and material assessment of the device confirmed it met print specifications.There are no indications that would suggest the device did not meet product specifications upon release into distribution.

Event Description

The tip of the offset aimer broke off during the positioning of the aimer.No patient or other complications were reported.

• Brand Name: AIMER ENDOFEMORAL 5MM OFFSET (RED)
• 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 ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5959537
• MDR Text Key: 55375130
• Report Number: 1219602-2016-00658
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• 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
• Report Date: 02/12/2016

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: 72201715
• Device Lot Number: 50448457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2016
• Initial Date FDA Received: 09/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1