MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DISPOSABLE BL,4.5MM FR ELITE; SAW, POWERED, AND ACCESSORIES

Catalog Number 7210499

Device Problem Metal Shedding Debris (1804)

Patient Problem No Code Available (3191)

Event Date 11/10/2013

Event Type  malfunction  

Manufacturer Narrative

Evaluation was not possible, as the device has not been returned.Due to this fact it is not possible to determine what may have caused the user to experience the reported incident.In the event the samples are returned for evaluation the complaint will be reopened for additional investigation.(b)(4).

Event Description

During a knee arthroscopy procedure it was reported that when the shaver was being used in the knee, it released metal shavings.The shavings were removed with a new shaver.No patient injury and a less than five minute delay were reported.The device will not be returned for evaluation.

• Brand Name: DISPOSABLE BL,4.5MM FR ELITE
• Type of Device: SAW, POWERED, AND ACCESSORIES
• 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 ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5067396
• MDR Text Key: 26023488
• Report Number: 1219602-2015-00973
• Device Sequence Number: 1
• Product Code: HAB
• 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: Medical Equipment Company Technician/Representative
• Report Date: 11/12/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7210499
• Device Lot Number: 50137570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/12/2013
• 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