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 Insufficient Information (4580)

Event Date 04/17/2020

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 gender, patient weight, ethnicity, race, relevant tests/laboratory data, concomitant medical products and therapy dates, lot #, explant date, device mfr date, removal action #.An attempt was made to obtain additional information: in a phone conversation with the sales representative he stated he did not have any additional information.

Event Description

Dr.(b)(6) had a 1.8mm truss wire break during a surgery at (b)(4) hospital on (b)(6) 2020.Posting by surgeon on (b)(4): "surgery performed by dr.(b)(6), previous ttc with nail/ex-fix that became infected.Dr.Holmes removed the nail, placed an antibiotic nail, and added the revolution external fixation system to compress through the nail using three half-rings to the tibia.Distal ring was flipped 180 degrees to match up with the foot plate, allowing him to compress across the ankle joint with three bolts." field rep.Stated that "i was in the case i don't recall a wire breaking during surgery on (b)(6) 2020.We did remove two wires so we can assemble the forefoot bridge.The frame was tension before and then we tried to assemble the bridge.At that time we had to remove two wires.When we removed an ankle fusion nail.There was a piece of a 1.8 wire that was broken from the original surgery and had to be removed as the patient had a bad infection.It was near the top of ankle fusion nail.A 2-3 cm piece of a wire was broken from the original surgery.".

• 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: 13082780
• MDR Text Key: 289903919
• Report Number: 3015536247-2020-00008
• 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: Administrator/Supervisor
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/23/2020

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: 04/29/2020
• 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
• Treatment: EXTERNAL FIXATION SYSTEM - NOT A METALOGIX PRODUCT