MAUDE Adverse Event Report: PARAGON 28, INC JAWS NITINOL STAPLE SYSTEM; JAWS STAPLE SYSTEM, DRILL GUIDE STRAIGHT, 2.3MM, 15MM

Model Number P70-941-2315

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

Product inspection verified failure mode.Lot number was not able to be identified; investigation verified it is one of the 2 lot numbers listed.If further information is identified which alters this event's conclusion, a supplemental report will be filed accordingly.Report 1 of 2.

Event Description

4 paragon 28 jaws staples were used for a lisfranc dislocation.While drilling, one of the metal sleeves within the drill guide came out and molded/fused itself onto the drill bit.Report 1 of 2.

• Brand Name: JAWS NITINOL STAPLE SYSTEM
• Type of Device: JAWS STAPLE SYSTEM, DRILL GUIDE STRAIGHT, 2.3MM, 15MM
• Manufacturer (Section D): PARAGON 28, INC; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: jenny conger ; 14445 grasslands dr; englewood, CO 80112 ; 8557862828
• MDR Report Key: 12482407
• MDR Text Key: 272877947
• Report Number: 3008650117-2021-00108
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170923
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P70-941-2315
• Device Catalogue Number: P70-941-2315
• Device Lot Number: 232676-93716 OR 5226231-93716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 58 YR