MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN JUGGERLOC; FIXATION

Model Number N/A

Device Problem Positioning Failure (1158)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Medical devices: f&a-juggerloc-implant-unk lot#unk item#unk.The reported event could not be confirmed based on limited information received.No products were returned; therefore, the visual and dimensional inspections were not performed.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.The compatibility check and complaint history search were not performed.A definitive root cause cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.Multiple mdr reports were filed for this event, please see associated report: 0001825034-2018-00092.

Event Description

It was reported that the patient underwent a left ankle syndesmosis procedure.During the procedure, the surgeon deployed the first juggerloc with no issues.The surgeon then inserted the second juggerloc anchor into the tibia and as he went to remove the inserter, the anchor pulled out with the inserter.The surgeon then reloaded the anchor to try a second attempt and the anchor zipped down and pulled through the tibial cortex.The surgeon then attempted an additional juggerloc, distal to the first two and the anchor also pulled out when the inserter was removed.The surgeon then completed the procedure with only the first jugglerloc implanted.No patient impact was reported.No further information was received.

• Brand Name: UNKNOWN JUGGERLOC
• Type of Device: FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7170664
• MDR Text Key: 96825808
• Report Number: 0001825034-2018-00092
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2017
• Initial Date FDA Received: 01/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1