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

Catalog Number 6200X0

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/07/2020

Event Type  malfunction  

Event Description

Patient: female, 18 y/o, healthy with good quality bone.Occurrence: dr.(b)(6) was inserting the half-pin with a power drill (not by hand).Pin passed thru 1st cortex normally, indicated extra force had to be applied to drill to continue the insertion, half-pin started inserting into the second cortex and he heard a pop, the tip broke.He left the pin in place and the metal will be left in the patient with the half-pin is removed in approx 3-6 weeks.

Manufacturer Narrative

The following information is omitted from this report as it is not available.Two follow-up attempts were made to secure this information from the initial reporter but none is available at the time this report was submitted.

• 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: 13564217
• MDR Text Key: 296388770
• Report Number: 3015536247-2020-00072
• 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: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6200X0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2020
• 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
• Removal/Correction Number: CR-20-002
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Sex: Female