MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BURR 5.5 ABRADER 180 LG HIGH VIS DSPL.; SAW, POWERED, AND ACCESSORIES

Catalog Number 72203127

Device Problem Material Integrity Problem (2978)

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

Event Date 08/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a hip scope procedure, the device shed metal flakes into the patient.The surgeon flushed out the debris.There was no further need for this device in the procedure, so a backup device was not necessary.No patient injury or complications were reported.

Manufacturer Narrative

Heavy metal debridement was detected on the bushing as well as the proximal end of the inner burr with corresponding debridement on the outer sheath of the used burr.Additional unused burrs from the same batch number were inspected for any cosmetic/visual imperfections and were also functionally tested (unloaded condition); all parts met drawing specifications and functioned as designed.The device issue may be related to the operator's technique or use environment.

• Brand Name: BURR 5.5 ABRADER 180 LG HIGH VIS DSPL.
• 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 ; 5123585706
• MDR Report Key: 5933061
• MDR Text Key: 54587129
• Report Number: 1219602-2016-00565
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/11/2016

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 Expiration Date: 01/13/2019
• Device Catalogue Number: 72203127
• Device Lot Number: 50610926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2016
• Initial Date FDA Received: 09/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2016
• 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