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

Model Number	N/A
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that before being opened to the sterile field, the box for the screw was opened; it was noticed that there were pin hole marks in the sterile packaging.The screw was not used.There was no patient involvement.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).The product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: g3; h2; h3; h6 -visual evaluation of the returned product found damage to the sterile pouch (puncture).Damage to the outer carton was also noted; however, as the outer carton damage was not initially reported, no further investigation will be performed.-review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.-reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.-the condition of the device when it left zimmer biomet is considered non-conforming to specification.The root cause of the reported event can be attributed to packaging operator not following the work instructions provided.-this complaint was confirmed by evaluation of the returned product.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.
Event or Problem Description
No further information is available at the time of this report.

• Brand Name: G7 ACETABULAR SCREW 6.5MM X 15MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19499782
• Report Number: 0001825034-2024-01535
• Device Sequence Number: 7926092
• Product Code: PBI
• UDI-Device Identifier: 00880304527447
• UDI-Public: (01)00880304527447(17)330610(10)7543659
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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: 7543659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown