MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BLADE,5.5MM,SER 3000; SAW, POWERED, AND ACCESSORIES

Catalog Number 7206010

Device Problems Material Discolored (1170); Metal Shedding Debris (1804)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2014

Event Type  malfunction  

Manufacturer Narrative

Patient was described as young.Evaluation was not possible, as the device has not been returned.Due to this fact we are unable to determine what may have caused the user to experience the reported incident.A review of the device history record was performed which confirmed no inconsistencies.No further investigation is necessary at this time.(b)(4).

Event Description

During a rotator cuff repair procedure, it was reported that the doctor noticed the blade had shed shavings into the joint; he was able to flush out the shavings.Additional information received stated that the blade was flush; with periods of 45 degree and that there was bone and tissue resection during the case.The surgeon was certain there were no fragments left in the patient.It was stated that the surgeon was previously using a product and inadvertently given a similar but different device (complained).He was applying a lot of pressure to get the same resection as the correct device.A back-up correct device was opened and utilized.It was additionally reported that the blade had discoloration.The post-operative condition of the patient indicated no issue and cleared.The facility discarded the product so no product will be received.

• Brand Name: FULL RADIUS BLADE,5.5MM,SER 3000
• 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: 4964535
• MDR Text Key: 23419956
• Report Number: 1219602-2015-00681
• 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: 02/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Catalogue Number: 7206010
• Device Lot Number: 50773669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2014
• Date Device Manufactured: 11/14/2013
• 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