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 Metal Shedding Debris (1804)

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

Event Date 10/30/2013

Event Type  malfunction  

Manufacturer Narrative

One burr, 5.5 abrader,1 80 lg, high vis, dspl was returned for evaluation of the reported complaint mode, ¿excessive shedding¿.The device was inspected dimensionally and found to meet design requirements.Functional inspection was performed and the inner blade rotated freely within the outer blade, no friction was felt in the unloaded condition.Visual inspection was performed and galling of the inner blade shaft was observed.Additionally the adapter body was cracked indicating excessive lateral load during rotation.A review of the device history record was performed which confirmed no inconsistencies (method code).After the evaluation the root cause could not be determined.The company will continue to analyze additional complaints as they are reported.(b)(4).

Event Description

During a hip arthroscopy procedure it was reported that there was excessive shedding.The surgeon used a shaver blade to remove the debris.A back up device was available to complete the case.There was a slight delay and no reported patient injuries or complications.

• 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 01810 ; 5123585706
• MDR Report Key: 4946310
• MDR Text Key: 23092468
• Report Number: 1219602-2015-00542
• 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: Health Professional
• Report Date: 07/28/2015

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: 12/31/2015
• Device Catalogue Number: 72203127
• Device Lot Number: 50736776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2013
• 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