MAUDE Adverse Event Report: BIOMET, INC. JUGGERKNOT SOFT ANCHORS; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 912068

Device Problems Break (1069); Component Missing (2306)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/09/2019

Event Type  malfunction  

Event Description

After juggerknot was inserted, the inserting instrument was assessed and one of the two fingers on the inserter was missing, appearing to have broken off.It was discussed and determined the finger broke off inside the bone under the anchor, the surgeon stated he thought it was acceptable to leave it in the bone; attempting to retrieve it would cause more harm.

• Brand Name: JUGGERKNOT SOFT ANCHORS
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): BIOMET, INC.; 56 east bell dr. p.o. box 587; warsaw IN 46582
• MDR Report Key: 9871748
• MDR Text Key: 184679919
• Report Number: 9871748
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00880304509641
• UDI-Public: (01)00880304509641
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 912068
• Device Catalogue Number: 912068
• Device Lot Number: 047800
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/20/2020
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5840 DA