MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INCISOR PLUS,ELITE, POWER-MINI DISP 2.9; SAW, POWERED, AND ACCESSORIES

Catalog Number 72201513

Device Problems Metal Shedding Debris (1804); Naturally Worn (2988)

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

Event Date 03/27/2013

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated for shedding.The device was observed to have sustained stress cracks on the adapter body at the base of the outer tube.The device was inspected for runout and it was observed that the tube had sustained a bend in excess of design tolerance.The bend in the tube, coupled with stress cracks in the adapter body are consistent with excessive lateral load which resulted in shedding.A review of the device history record was performed which confirmed no inconsistencies.After evaluation a root cause for the reported event was found to be user error.No further investigation is necessary at this time.(b)(4).

Event Description

During a small joint wrist procedure, it was reported that filings were left in the articular during surgery.It was stated that it was worn-out in front of the inner blade, just before lumen.The surgeon was using the shaver blade in the small joint of the wrist and it began to shed when he started to use it.The surgeon managed to remove the fillings by using another shaver blade.There were no reported patient injuries or complications.A few minute delay was experienced.

• Brand Name: INCISOR PLUS,ELITE, POWER-MINI DISP 2.9
• 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: 5005227
• MDR Text Key: 24293495
• Report Number: 1219602-2015-00781
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Report Date: 04/10/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2013
• Device Catalogue Number: 72201513
• Device Lot Number: 50707584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2012
• 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