MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BURR,SLAP,4.5MM DSPL,DYO PWR /6; SAW, POWERED, AND ACCESSORIES

Catalog Number 7209335

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

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

Event Date 01/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Examination was not possible, as the device will not be returned.Without the return of the device in question a root cause for the reported incident cannot be determined.No abnormalities were reported with this product during manufacture.There are no indications that would suggest the device did not meet product specifications upon release into distribution.

Event Description

While performing a knee arthroscopy, the protective cover on the slap burr shaver end became detached from the shaver end.The piece of metal broke off along the weld line of the arthroscopic shaver end and was then floating inside the knee.The piece was removed from the knee.No patient injury or other complications were reported.

• Brand Name: BURR,SLAP,4.5MM DSPL,DYO PWR /6
• 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: jim gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5973069
• MDR Text Key: 55735013
• Report Number: 1219602-2016-00938
• 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: Other
• Type of Report: Initial
• Report Date: 01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/01/2019
• Device Catalogue Number: 7209335
• Device Lot Number: 50792843
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2016
• Date Device Manufactured: 02/24/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1