MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. 2.8 X 5.0MM SELF DRILLING SCREW; GALLERY LAMINOPLASTY FIXATION SYSTEM

Catalog Number	14-523100
Medical Device Problem Codes	Missing Information (4053); Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
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.
Event or Problem Description
It was reported that a 2.4x5mm gallery self-drilling screw was found in packaging labelled for a 2.8x5mm screw.It was also mentioned that only the lot numbers were engraved on the screws themselves.This was sent to a hospital and was found to contain the incorrect part/lot upon return to the warehouse; the screw was not used.
Event or Problem Description
It was reported that a 2.4x5mm gallery self-drilling screw was found in packaging labelled for a 2.8x5mm screw.It was also mentioned that only the lot numbers were engraved on the screws themselves.This was sent to a hospital and was found to contain the incorrect part/lot upon return to the warehouse; the screw was not used.
Additional Manufacturer Narrative
Corrections in d9 and h3.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed no signs of damage.A dimensional inspection was performed on the major thread diameter with a micrometer (eq-0282 cal.Due 3/20/2025) and found the dimension to measure.093", which indicates this is a 2.4mm screw (pn 14-523095) per drawing 14-523095-00.It seems the packaged device was marked with the incorrect lot number.Root cause: the root cause was found to be that a single screw remained in the catch bin then was mixed into the next lot of screws that was next run in the machine.It was subsequently etched and labeled with the incorrect screw information.Dhr review: the dhr was reviewed.It was initially recorded there were no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left highridge¿s control.It was found that this part had packaging with an incorrect part number and the part was labeled with the incorrect lot number.Device usage: 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.

• Brand Name: 2.8 X 5.0MM SELF DRILLING SCREW
• Common Device Name: GALLERY LAMINOPLASTY FIXATION SYSTEM
• 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: 20021347
• Report Number: 3012447612-2024-00225
• Device Sequence Number: 8600954
• Product Code: NQW
• UDI-Device Identifier: 00880304960350
• UDI-Public: (01)00880304960350(10)5011801
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100805
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2025

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: 14-523100
• Device Lot Number: 5011801
• 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: 08/21/2024
• Supplement Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2024
• 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: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic