MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LOCK DIST TIB MED RT 9H STE; PLATE, FIXATION

Model Number	8562-10-009
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 856211006 045420 lock dist tib med lt 6h ste, 856210009 950980 lock dist tib med rt 9h ste, 856211006 045420 lock dist tib med lt 6h ste.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 mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -  2022 -  02557, 0001825034 -  2022 -  02558, 0001825034 -  2022 -  02559.
Event or Problem Description
It was reported during the incoming inspection at warehouse that the sterile package was not vacuumed.No adverse event has been reported as a result of the malfunction.
Additional Manufacturer Narrative
Upon receipt of additional information, it has been determined that the packaging meets the standards of inspection criteria.No product failure was found as the products are within specifications.The initial report was forwarded in error and should be voided.
Event or Problem Description
Upon receipt of additional information, it has been determined that the packaging meets the standards of inspection criteria.No product failure was found as the products are within specifications.The initial report was forwarded in error and should be voided.

• Brand Name: LOCK DIST TIB MED RT 9H STE
• 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: 15779112
• Report Number: 0001825034-2022-02556
• Device Sequence Number: 15136549
• Product Code: HRS
• UDI-Device Identifier: 00887868062056
• UDI-Public: (01)00887868062056(17)320413(10)950980
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111663
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2022

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: 8562-10-009
• Device Catalogue Number: 856210009
• Device Lot Number: 950980
• 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: 10/28/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 11/11/2022
• Supplement Report FDA Received Date: 12/06/2022
• Date Device Manufactured: 04/13/2022
• 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