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

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
Additional 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.Product as not yet returned.
Event or Problem Description
It was reported that the product packaging was found to be nonconforming.The incoming inspection team found debris and blood like debris in the sterile package.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No additional information on the reported event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d9; g3; h2; h3; h4; h6 visual evaluation of the returned products identified that there is debris inside the sterile packages.The complaint has been confirmed by visual evaluation.Review of the device history records identified no related deviations or anomalies.These products likely left zimmer biomet control non-conforming.The root cause of the reported issue is attributed to the operator not following instructions during manufacturing.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
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11343094
• Report Number: 0001825034-2021-00529
• Device Sequence Number: 17392622
• Product Code: PBI
• UDI-Device Identifier: 00880304527447
• UDI-Public: (01)00880304527447(17)301216(10)6932088
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000996
• Device Lot Number: 6932088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1