MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 16MM STEPPED GROWTH CON PLATES; PROSTHESIS, TRAUMA

Model Number	N/A
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
Product was returned with sterility barrier potentially compromised.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual inspection of the outer box shows that the original shrink wrap is not present with a damaged carton.The damage to the carton is within acceptable limits per cosmetic requirements for inbound and outbound shipments.The product was received with the inner pouch opened likely by the customer.Complaint sample was evaluated and the reported event was confirmed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The condition of the device when it left zimmer biomet is conforming to specification.The root cause of the reported issue is attributed to transit damage.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: 16MM STEPPED GROWTH CON PLATES
• Common Device Name: PROSTHESIS, TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11116201
• Report Number: 0001825034-2021-00008
• Device Sequence Number: 3608544
• Product Code: HRS
• UDI-Device Identifier: 00880304500433
• UDI-Public: (01)00880304500433
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K093880
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2021

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: 24616
• Device Lot Number: 142890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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