MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JGRLOC B2B RD TI SLD DRL KIT; EXTREMITIES, IMPLANT

Model Number N/A

Device Problem Positioning Failure (1158)

Patient Problem No Code Available (3191)

Event Date 05/21/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Udi# (b)(4).Concomitant medical products: item# 110007345; jgrloc b2b rd ti sld drl kit; lot# 241040.Complaint sample was evaluated and the reported event was confirmed.Inspection of the returned device identified fraying and cuts in the sutures near the buttons.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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 reports: 0001825034-2019-02447.

Event Description

It was reported that during a surgery, the titanium button of the juggerloc did not fully zip down, leaving several millimeters of slack in the suture material.There was a delay of 30 minutes as a result of this event.No additional patient consequences were reported.

• Brand Name: JGRLOC B2B RD TI SLD DRL KIT
• Type of Device: EXTREMITIES, IMPLANT
• 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: 9079055
• MDR Text Key: 159104837
• Report Number: 0001825034-2019-04167
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 110007345
• Device Lot Number: 241040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/17/2019
• Initial Date FDA Received: 09/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2018
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 53 YR