MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 SCREW 6.5MM X 20MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 07/21/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).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.

Event Description

It was reported that during incoming inspection team member found open sterile package.The sterile package was never sealed.There was no patient involvement.No additional information is available.

Event Description

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

Manufacturer Narrative

Cmp-(b)(4).Reported event was confirmed by visual examination of device.Device history record (dhr) was reviewed and no discrepancies were found.The root cause of the reported event can be attributed to the operator not following instructions during manufacturing.Visual evaluation of the returned product identified that the sterile packaging pouch has not been sealed on one side.The product was likely non-conforming when it left zimmer biomet control.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.

• Brand Name: G7 SCREW 6.5MM X 20MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10349794
• MDR Text Key: 201222798
• Report Number: 0001825034-2020-03002
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304527454
• UDI-Public: 00880304527454
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• 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: 010000997
• Device Lot Number: 6792197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1