MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 SCREW 6.5MM X 15MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Unsealed Device Packaging (1444); Insufficient Information (3190)

Patient Problems No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)

Event Date 08/28/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported there was debris either in the packaging or the package was damaged, no patient involvement was reported.Attempts have been made and no additional information is available.

Event Description

No further event information is available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Report source : japan.The returned product was visually inspected and the reported event was confirmed.A review of the device history records did not identify any deviations or anomalies during the manufacturing process.The likely condition of the products when they left zimmer biomet was non-conforming.The root cause of the reported event is due to the deficiency in manufacturing process.A corrective action has been initiated to address this manufacturing deficiency.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: G7 SCREW 6.5MM X 15MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7903047
• MDR Text Key: 121564430
• Report Number: 0001825034-2018-09104
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000996
• Device Lot Number: 6315844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1