MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JGRLOC B2B RD TI SLD DRL KIT; WASHER, BOLT NUT

Model Number N/A

Device Problems Knotted (1340); Difficult To Position (1467)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the tightening mechanism on the juggerloc knotted up when tensioning it down to the plate pulling the syndesmosis together.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during ankle syndesmosis procedure, the tightening mechanism on the juggerloc knotted up when tensioning the button down to the plate.The juggerloc was removed from the patient, and screws were put in to hold the syndesmosis.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: JGRLOC B2B RD TI SLD DRL KIT
• Type of Device: WASHER, BOLT NUT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7352657
• MDR Text Key: 102882111
• Report Number: 0001825034-2018-02028
• Device Sequence Number: 1
• Product Code: HTN
• Combination Product (y/n): N
• PMA/PMN Number: PK141219
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/25/2022
• Device Model Number: N/A
• Device Catalogue Number: 110007345
• Device Lot Number: 047840
• Other Device ID Number: (01) 00880304680326
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 84