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

Model Number	8562-11-009
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2022
Type of Reportable Event	Malfunction
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 mdr will be submitted.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
It was reported that the sterile package was not vacuumed.No adverse events have been reported as a result of the malfunction.
Additional Manufacturer Narrative
Upon evaluation of the returned product, it has been determined that the packaging meets the standards of inspection criteria.This complaint cannot be confirmed as the product was found to be conforming.The initial report was forwarded in error and should be voided.
Event or Problem Description
Upon evaluation of the returned product, it has been determined that the packaging meets the standards of inspection criteria.The initial report was forwarded in error and should be voided.
Event or Problem Description
No additional event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: cat: 856211009 lot: 762010 lock dist tib med lt 9h ste; cat: 856211009 lot: 762010 lock dist tib med lt 9h ste; cat: 856211009 lot: 762010 lock dist tib med lt 9h ste.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned product found the vacuum seal was no longer intact.The product has been found to be non-conforming.Device history record (dhr) was reviewed and no discrepancies were found.The condition of the device when it left zimmer biomet is non-conforming to specification.The root cause of the reported event is the operator not following the work instructions provided.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 01985; 0001825034 - 2022 - 01986; 0001825034 - 2022 - 01987.

• Brand Name: LOCK DIST TIB MED LT 9H STE
• Common Device Name: PIN, 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: 15294167
• Report Number: 0001825034-2022-01915
• Device Sequence Number: 20381522
• Product Code: JDW
• UDI-Device Identifier: 00887868449765
• UDI-Public: (01)00887868449765(17)320718(10)762010
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,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: 8562-11-009
• Device Catalogue Number: 856211009
• Device Lot Number: 762010
• 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: 08/15/2022
• Supplement Date Received by Manufacturer: 10/21/2022; 11/29/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 11/16/2022; 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H10
• Patient Sex: Unknown