MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BLADE,3.5MM,DISP; SAW, POWERED, AND ACCESSORIES

Catalog Number 7205305

Device Problem Material Integrity Problem (2978)

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

Event Date 07/03/2013

Event Type  malfunction  

Manufacturer Narrative

The facility returned three used blades for evaluation; they did not identify which blade was involved in this reported incident.Two of the three blades spun freely, one did not spin freely.All of the adapter bodies show significant cracking, consistent with excessive lateral load during use.All of the inner blades show minimal abrasion at the tip, with the exception of the blade that did not spin freely.The likely cause of the shedding is fracturing of the adapter body allowing for misalignment with the inner blade causing friction and resulting in shedding.A review of the device history record was performed which confirmed no inconsistencies.After the evaluation, the root cause was determined to be user error.No further investigation is necessary at this time.(b)(4).

Event Description

During a knee arthroscopy procedure, it was reported that the blade shed while in use.The doctor was able to retrieve the pieces that shed from the blade by suction.The doctor switched to another blade and had no problems.There were no reported delays, patient injuries or complications.

• Brand Name: FULL RADIUS BLADE,3.5MM,DISP
• 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: 4976595
• MDR Text Key: 23804979
• Report Number: 1219602-2015-00665
• 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,consum
• Reporter Occupation: Other
• Report Date: 07/10/2013

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: 02/28/2018
• Device Catalogue Number: 7205305
• Device Lot Number: 50724033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2013
• 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