MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYNOVATOR BLADE,BOXED4.5 EP-1; SAW, POWERED, AND ACCESSORIES

Model Number 7205310

Device Problems Material Fragmentation (1261); Metal Shedding Debris (1804)

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

Event Date 05/29/2018

Event Type  malfunction  

Event Description

It was reported that the device was shedding during procedure.All fragments were removed from the patient.A backup device was available to complete the procedure with no significant delay and no patient injuries.

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,BOXED4.5 EP-1
• 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: 7562967
• MDR Text Key: 110002906
• Report Number: 1219602-2018-00688
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010251381
• UDI-Public: (01)03596010251381(17)220911(10)50684506
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2022
• Device Model Number: 7205310
• Device Catalogue Number: 7205310
• Device Lot Number: 50684506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2018
• Date Device Manufactured: 09/11/2017
• 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