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

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 01723.

Event Description

It was reported that during the surgery two jugger locs were pulled out from the patient bone.No additional information is available for this event.

Manufacturer Narrative

The following report is being submitted to relay additional information received: the complaint cannot be confirmed as no medical records were provided.Review of the device history records identified no related deviations or anomalies.Root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional information is available to report.

• Brand Name: JGRLOC B2B RD TI SLD DRL KIT
• Type of Device: FASTENER, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8539347
• MDR Text Key: 142751410
• Report Number: 0001825034-2019-01724
• Device Sequence Number: 1
• Product Code: HTN
• Combination Product (y/n): N
• PMA/PMN Number: K141219
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2023
• Device Model Number: N/A
• Device Catalogue Number: 110007345
• Device Lot Number: 294490
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 110007345 JGRLOC B2B RD TI SLD DRL KIT 892030; 110007345 JGRLOC B2B RD TI SLD DRL KIT 892030