MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DVR LOCK STANDARD L ST; PROSTHESIS, PLATE, TRAUMA

Catalog Number	131822051
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Foreign source: event occurred in japan.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.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 during product inspection in the warehouse, the product is out of the protective cover.No patient was involved.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual evaluation of returned product found the device is not fully seated in the blue protective pouch.The intent of the blue pouch is to protect the device and outer pouch from damage and abrasion that could result in a loss of sterility.A review of the packaging instructions and inspection criteria do not list any details regarding how to place the device in the blue pouch.The device would be considered conforming.The packaging configuration and applicable packaging instructions have since been updated.Reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.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 event is the operator not following the work instructions provided.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: DVR LOCK STANDARD L ST
• Common Device Name: PROSTHESIS, PLATE, TRAUMA
• 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: 14843468
• Report Number: 0001825034-2022-01509
• Device Sequence Number: 11354696
• Product Code: LXT
• UDI-Device Identifier: 00887868446283
• UDI-Public: (01)00887868446283(17)320412(10)905990
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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): 11/01/2022

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 Catalogue Number: 131822051
• Device Lot Number: 905990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2022
• 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: NI
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose