MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BOXED INCISOR PLUS BL (BX6); SAW, POWERED, AND ACCESSORIES

Model Number 7205345

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case-(b)(4).

Event Description

It was reported that during a surgery, when the incisor biade entered into the patient body, something bright fell off.The procedure was successfully completed without a significant delay using a back-up device.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

• Brand Name: BOXED INCISOR PLUS BL (BX6)
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 10991263
• MDR Text Key: 220903456
• Report Number: 1219602-2020-02039
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010251688
• UDI-Public: 03596010251688
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7205345
• Device Catalogue Number: 7205345
• Device Lot Number: 50828103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male