MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. POLYAXIAL SMOOTH SHANK SCREW (DIA.3.5 MM X 34 MM L); APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	07.01707.013
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
Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference reports 3012447612-2025-00336 through 3012447612-2025-00338.
Event or Problem Description
A distributor reported receiving three 4.0x26 polyaxial smooth shank screws in packaging labelled for 3.5x34 screws.This was discovered prior to surgical use and there was no patient involvement.This is report three of three for this event.
Additional Manufacturer Narrative
Corrections in d9 and h3.Additional information in h6: investigation type, findings, and conclusions.A visual inspection revealed the packaged screw is part number 07.01707.024 however, the label on the package is for part number 07.01707.013.A review of the initial dhr indicated that the device was likely conforming when it left (b)(6) control.However, based on the inspection of the returned device, it is now known that the device was not conforming.The part looks to have gone through the bag and tag process where it was relabeled and it appears that the incorrect part number was entered on the label during this relabeling process.An internal nc and hhed have been initiated to further investigate the nonconformance.The complaint is confirmed for virage screw for the failure of the package label not matching the device when received.The failure could possibly be attributed to improper packaging practices related to product identification.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 receiving three 4.0x26 polyaxial smooth shank screws in packaging labelled for 3.5x34 screws.This was discovered prior to surgical use and there was no patient involvement.This is report three of three for this event.

• Brand Name: POLYAXIAL SMOOTH SHANK SCREW (DIA.3.5 MM X 34 MM L)
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• 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: 23426762
• Report Number: 3012447612-2025-00338
• Device Sequence Number: 15517197
• Product Code: KWP
• UDI-Device Identifier: 03662663111751
• UDI-Public: (01)03662663111751(10)62701695
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K133556
• 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): 04/26/2026

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: 07.01707.013
• Device Lot Number: 62701695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/30/2025
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2014
• 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