MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CLAV DST SUP NRW RT 9H 55MM ST; PLATE, FIXATION

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the sterile package was not vacuumed.No further information is available at this time.
Additional Manufacturer Narrative
(b)(4).Report source: foreign: 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 report will be submitted.Product not returned.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Evaluation of the returned product found the packaging meets the standards of inspection criteria.Review of the device history record(s) identified no deviations or anomalies during manufacturing.No product failure was found as the products are within specifications.No further investigation or action is required after review.This complaint will be considered not reportable as there was no device problem.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: CLAV DST SUP NRW RT 9H 55MM ST
• Common Device Name: PLATE, FIXATION
• 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: 15976031
• Report Number: 0001825034-2022-02782
• Device Sequence Number: 12511865
• Product Code: HRS
• UDI-Device Identifier: 00889024055537
• UDI-Public: (01)00889024055537(17)320803(10)RM461R
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: NOT LISTED
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2022

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: 132013055
• Device Lot Number: RM461R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/22/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown