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

Catalog Number 7209335

Device Problem Detachment Of Device Component (1104)

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

Event Date 01/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Examination was not possible, as the device will not be returned.The investigation was limited to the information provided.The investigation could not draw any conclusions about the reported event without the return of the device.There are no indications that would suggest the device did not meet product specifications upon release into distribution.(b)(4).

Event Description

During surgery while using the burr the shielded element of the burr snapped off into the knee joint.The surgeon removed the part from the patient.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: 5975477
• MDR Text Key: 55888060
• Report Number: 1219602-2016-00940
• 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,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/27/2016

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: Health Professional
• 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?: Yes
• Date Manufacturer Received: 01/27/2016
• 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