MAUDE Adverse Event Report: PARAGON 28, INC PHANTOM HINDFOOT TTC/TC NAIL SYSTEM SLAP HAMMER

Model Number P99-150-2002

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 09/15/2021

Event Type  malfunction  

Event Description

Threading issue with the slap hammer delayed surgery 45 minutes; limited information.

• Brand Name: PHANTOM HINDFOOT TTC/TC NAIL SYSTEM
• Type of Device: SLAP HAMMER
• Manufacturer (Section D): PARAGON 28, INC; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: jenny conger ; 14445 grasslands dr; englewood, CO 80112
• MDR Report Key: 12582757
• MDR Text Key: 276362459
• Report Number: 3008650117-2021-00117
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201227
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/06/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: P99-150-2002
• Device Catalogue Number: P99-150-2002
• Device Lot Number: 9156883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse