MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN LAG SCREW 10.5MM X 80MM; TRAUMA IMPLANTS

Model Number	N/A
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the distributorship that the incoming inspection team member found a scratch on the sterile package.It is unknown if the sterility of the packaging was breached.Attempts have been made and there is no further information at this time.
Additional Manufacturer Narrative
(b)(4).Report source: japan.Device evaluated by mfr: 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 will be returned.
Additional Manufacturer Narrative
(b)(4).Reported event was confirmed as visual evaluation of the returned product found a scratch mark on the sterile pouch that is not acceptable.This kind of issue can happen when handling the pouch.All products are controlled before packaging in box as per specific protocol.The pouch was removed from the outer carton by the customer; therefore, it cannot be confirmed when the failure occurred or if the product left zimmer biomet non-conforming.This complaint has been confirmed by evaluation of the returned product.Sterility or breach thereof cannot be determined.Device history record was reviewed and no discrepancies relevant to the reported event were found.The root cause and the condition of the device when it left zimmer biomet cannot be determined.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 event information available at the time of this report.

• Brand Name: HFN LAG SCREW 10.5MM X 80MM
• Common Device Name: TRAUMA IMPLANTS
• 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: 16582953
• Report Number: 0001825034-2023-00571
• Device Sequence Number: 14639498
• Product Code: HSB
• UDI-Device Identifier: 00887868038983
• UDI-Public: (01)00887868038983(17)321130(10)ZD1112280C
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2023

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: 814510080
• Device Lot Number: ZD1112280C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown