MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JGRLOC UNICORTICAL FIX DEV; SPORT MED IMPLANT

Model Number N/A

Device Problem Bent (1059)

Patient Problem No Information (3190)

Event Date 01/04/2016

Event Type  malfunction  

Manufacturer Narrative

Product has been received by zimmer biomet.Without the opportunity to examine the complaint product, root cause cannot be determined.Review of complaint history found no additional related issues for this part.Review of device history records found these units were released to distribution with no deviations or anomalies.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.This report is being submitted late as it has been identified in remediation.

Event Description

It was reported that during a proximal biceps repair procedure on (b)(6), the inserter bent during impaction and the juggerknot fell off.Another juggerknot was used to complete the procedure with no delay.No additional holes had to be drilled and the juggerknot did not fall into the patient.

• Brand Name: JGRLOC UNICORTICAL FIX DEV
• Type of Device: SPORT MED 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: 6940864
• MDR Text Key: 90292517
• Report Number: 0001825034-2017-08453
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK141263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/11/2017

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: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 110017314
• Device Lot Number: 293970
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2016
• Initial Date FDA Received: 10/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2015
• 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