MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. 4.0MM X 16MM VARIABLE SCREW; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	14-521616
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
Event or Problem Description
A distributor reported that they received a maxan 4.0x12 variable screw in packaging for maxan 4.0x16 variable screws.There was no patient involvement.
Additional Manufacturer Narrative
H3: "device evaluation anticipated, but not yet begun" is erroneous and no longer applies.The device was evaluated.Corrections in h3.Additional information in h6: investigation type, findings, and conclusions.The "loose inventory repack traveler" dhr indicated that the device one piece for pn 14-521616 lot j27914 went through bag & tag on may 14, 2025.The laser marking and thread length of the screw confirmed it is pn 14-521612 lot j27914; the incorrect pn was recorded on the dhr and the label.Since this was repackaged and labeled in may 2025, prior to the actions being implemented for an internal capa in june 2025, this event is within the scope of the capa and no further actions are required.The complaint is confirmed for maxan screw for the failure of incorrect part/product in package.The failure could possibly be attributed to improper packaging practices related to product identification.This device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
Event or Problem Description
A distributor reported that they received a maxan 4.0x12 variable screw in packaging for maxan 4.0x16 variable screws.There was no patient involvement.

• Brand Name: 4.0MM X 16MM VARIABLE SCREW
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer Contact: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; 3035018506
• MDR Report Key: 23544397
• Report Number: 3012447612-2025-00358
• Device Sequence Number: 13092059
• Product Code: KWQ
• UDI-Device Identifier: 03662663142618
• UDI-Public: (01)03662663142618(10)J27914
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K080646
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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: Other
• Device Catalogue Number: 14-521616
• Device Lot Number: J27914
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/29/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2025
• 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
• Patient Ethnicity: Non Hispanic