MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BONECUTTER, 5.5MM, PLATINUM; SAW, POWERED, AND ACCESSORIES

Model Number 72202530

Device Problem Metal Shedding Debris (1804)

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

Event Date 01/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the metalshaving drop from the blade during surgery, all the pieces were removed from the patient.No patient injury was reported.

Manufacturer Narrative

One 5.5mm full radius elite blade was returned for evaluation.Functional inspection was performed and the inner blade did not rotate freely within the outer blade, friction was felt in the unloaded condition.Visual assessment of the device showed it is bent.There is debridement of the inner blade approximately ½ inch from the slough channel confirming the reported shedding.The condition of the device indicates it was subjected to an excessive lateral load during use.User error might have been a contributive factor of the event.

• Brand Name: FULL RADIUS BONECUTTER, 5.5MM, PLATINUM
• 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 ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7275110
• MDR Text Key: 100431383
• Report Number: 1219602-2018-00228
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010655684
• UDI-Public: (01)03596010655684(17)200308(10)50684163
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2020
• Device Model Number: 72202530
• Device Catalogue Number: 72202530
• Device Lot Number: 50684163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2017
• 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