MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYNOVATOR BLADE,5.5MM,EP-1, DSPL BLADE; SAW, POWERED, AND ACCESSORIES

Model Number 7205311

Device Problem Material Disintegration (1177)

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

Event Date 08/27/2018

Event Type  malfunction  

Event Description

It was reported that tiny specs of metal did grind out of the device into the joint.No patient injury or significant delay were reported.A back up was used to complete the procedure.

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.

• Brand Name: SYNOVATOR BLADE,5.5MM,EP-1, DSPL BLADE
• 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: 7898989
• MDR Text Key: 121458481
• Report Number: 1219602-2018-01310
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010251398
• UDI-Public: (01)03596010251398(17)230215(10)50714958
• 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: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2023
• Device Model Number: 7205311
• Device Catalogue Number: 7205311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/15/2018
• 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
• Patient Age: 62 YR