MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 SCREW 6.5MM X 30MM; HIP PROSTHESIS

Model Number N/A

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 03/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 2nd screw: 0001825034-2019-01490.

Event Description

It was reported that the warehouse inspection member found the seal on the sterile packaging less than 6.35mm(1/4") in width.Attempts have been made and no further information has been provided.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

Udi#: (b)(4).Complaint sample was evaluated and the reported event was confirmed.Inspection of the returned device revealed the seal was defect.This is not a reportable event due to the fact that the sterility of the device was not compromised.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded the most likely root cause of the reported event is the operator not following instructions during the manufacturing process.Device history record (dhr) was reviewed and no discrepancies were found.The root cause of the reported event is the operator not following instructions during the manufacturing process.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 30MM
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8469688
• MDR Text Key: 140783579
• Report Number: 0001825034-2019-01489
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• 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: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• 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: 010000999
• Device Lot Number: 6478741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1