MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INCISOR BLADE,4.5 DSPL,EP-1(BX6); SAW, POWERED, AND ACCESSORIES

Model Number 7205313

Device Problems Break (1069); Material Too Rigid or Stiff (1544)

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

Event Date 08/15/2018

Event Type  malfunction  

Event Description

It was reported that the surgeon was using the blade for about 15 minutes and then it started to shearing and the inside of the shaver blade shaft became really stiff and couldnt be easily pulled apart to be cleaned.

Manufacturer Narrative

Examination was not possible, as the device has not been returned.The investigation could not draw any conclusions about the reported event without the return of the device.Further investigation is not warranted at this time.

• Brand Name: INCISOR BLADE,4.5 DSPL,EP-1(BX6)
• 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 ; 5123585706
• MDR Report Key: 7851796
• MDR Text Key: 119533162
• Report Number: 1219602-2018-01203
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010251411
• UDI-Public: (01)03596010251411(17)230216(10)50715136
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2023
• Device Model Number: 7205313
• Device Catalogue Number: 7205313
• Device Lot Number: 50715136
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/16/2018
• 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