MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BOXED INCISOR PLUS BL,(BX6); SAW, POWERED, AND ACCESSORIES

Catalog Number 7205345

Device Problems Material Fragmentation (1261); Metal Shedding Debris (1804)

Patient Problem Fluid Discharge (2686)

Event Date 01/17/2013

Event Type  malfunction  

Event Description

During a knee arthroscopy it was reported that while resecting the tissue metal debris was observed to be shedding into the joint.The surgeon removed the fragments by suction and with the flow of the internal fluids.There was no reported time delay.

Manufacturer Narrative

(b)(6).No product returned for evaluation.Evaluation was not possible, as the device is not being returned.Review of the device history records were performed which confirmed no inconsistencies.Due to the device not being returned a root cause could not be determined.No further investigation is necessary at this time.(b)(4).

• Brand Name: BOXED INCISOR PLUS BL,(BX6)
• 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: 4945287
• MDR Text Key: 6194052
• Report Number: 1219602-2015-00528
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: 7205345
• Device Lot Number: 50684739
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2012
• 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