MAUDE Adverse Event Report: NEW STANDARD DEVICE INC. REVOLUTION EXTERNAL PLATING SYSTEM; SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCES AND ACCESSORIES

Catalog Number 900217

Device Problem Fracture (1260)

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

Event Date 02/13/2020

Event Type  malfunction  

Manufacturer Narrative

The following information is omitted from this report as it was not available at the time the report was submitted: patient identifier, patient age, dob, patient gender, patient weight, ethnicity, race, relevant tests/laboratory data, concomitant medical products and therapy dates, device lot #, explant date, device mfr date, and removal action #.

Event Description

(b)(6)stated that: "dr.(b)(6) removed a revolution frame today and it had (4) broken truss wires.She has had broken truss wires before, (b)(6) indicated that dr.(b)(6) or the patient did not know that the wires were broken.".

• Brand Name: REVOLUTION EXTERNAL PLATING SYSTEM
• Type of Device: SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCES AND ACCESSORIES
• Manufacturer (Section D): NEW STANDARD DEVICE INC.; 4848 research drive; san antonio TX 78240 5005
• Manufacturer (Section G): NEW STANDARD DEVICE INC.; 4848 research drive; san antonio TX 78240 5005
• Manufacturer Contact: rachel grimes ; 4848 research drive; san antonio, TX 78240-5005 ; 8336592019
• MDR Report Key: 13082790
• MDR Text Key: 290156569
• Report Number: 3015536247-2020-00004
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053472
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 900217
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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