MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5X60MM CORT LOCK SCR STE; SCREW, PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4), concomitant medical products: item name: 3.5x60mm cort lock screw cat #: 856135060 lot# 942790 qty of (b)(4) total.Foreign source: japan.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: 0001825034 - 2022 - 02436, 0001825034 - 2022 - 02509, 0001825034 - 2022 - 02510, 0001825034 - 2022 - 02511, 0001825034 - 2022 - 02512 , 0001825034 - 2022 - 02513, 0001825034 - 2022 - 02514, and 0001825034 - 2022 - 02516.
Event or Problem Description
It was reported by the distributorship that the product was nonconforming, as the sterile package had scratch marks on it.Additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, g3, g6, h2, h3, h6, h10 -visual inspection of the returned product found there is a scratch on the inner pouch on all 9 products.The scratch does not go through the pouch.Sterility has not been compromised.This complaint has been confirmed.-review of the device history record(s) identified no deviations or anomalies during manufacturing.-a definitive root cause cannot be determined.- upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.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 is available at the time of this report.

• Brand Name: 3.5X60MM CORT LOCK SCR STE
• Common Device Name: SCREW, PROSTHESIS
• 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: 15770187
• Report Number: 0001825034-2022-02515
• Device Sequence Number: 12419790
• Product Code: HRS
• UDI-Device Identifier: 00887868352058
• UDI-Public: (01)00887868352058(17)300729(10)942790
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2022

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: 856135060
• Device Lot Number: 942790
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2022
• Supplement Date Received by Manufacturer: 12/05/2022
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2020
• 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