MAUDE Adverse Event Report: PARAGON 28, INC GRAPPLER SUTURE ANCHOR SYSTEM; GRAPPLER SUTURE ANCHOR, TITANIUM, Ø3.0 X 10MM, STERILE KIT, PRODUCT

Catalog Number P44-110-3010-SK

Device Problem Malposition of Device (2616)

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

Event Date 06/24/2022

Event Type  malfunction  

Event Description

Anchor disengaged from the driver during insertion.

• Brand Name: GRAPPLER SUTURE ANCHOR SYSTEM
• Type of Device: GRAPPLER SUTURE ANCHOR, TITANIUM, Ø3.0 X 10MM, STERILE KIT, PRODUCT
• 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: 15124451
• MDR Text Key: 297186767
• Report Number: 3008650117-2022-00099
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: P44-110-3010-SK
• Device Lot Number: 5007499
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 30 YR
• Patient Sex: Male
• Patient Weight: 68 KG