MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. TOP LOADING POLY SCREW ASSEMBLIES 7.5X50MM; VITALITY SPINAL FIXATION SYSTEM

Catalog Number	07.02000.118
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2023
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
It was reported that the length of the size laser marked on a vitality screw does not match the size that correlates with the laser marked part number.The laser marked part number is 07.02000.118, which should be a 7.5 x 50 screw.However, the size is laser marked 7.5 x 40mm.This was found discovered in the sterile department when placing the screw into the sterilization caddy.There was no patient involvement.This is report three of eight for this event.
Event or Problem Description
It was reported that the length of the size laser marked on a vitality screw does not match the size that correlates with the laser marked part number.The laser marked part number is 07.02000.118, which should be a 7.5 x 50 screw.However, the size is laser marked 7.5 x 40mm.This was found discovered in the sterile department when placing the screw into the sterilization caddy.There was no patient involvement.This is report three of eight for this event.
Additional Manufacturer Narrative
H9: 3012447612-10/20/2023-001-r.Corrections in h3; note: code 02 cannot be edited/removed but this no longer applies from the initial submission.Additional information in h6: component, investigation type, findings, and conclusions, h7 and h9.Device evaluation: visual inspection of the returned device found the package states the screw's size is 7.5mm x 50mm, however the screw is laser etched 7.5mm x 40mm.The length was checked and confirmed to be 50mm, so the laser etching is incorrect.Root cause: the incorrect etching was caused by a deficiency in the manufacturing process, which appears to be related to the manual editing of a general program in which the operator inputs the size information based on a tabular drawing with information for screws of multiple sizes.Further analysis of the manufacturing deficiency is occurring through a scar as part of the capa process.Dhr review: the manufacturing records were reviewed, but the incorrect etching was not identified during part inspection.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.Reference reports 3012447612-2023-00308 through 3012447612-2023-00315 for this event.

• Brand Name: TOP LOADING POLY SCREW ASSEMBLIES 7.5X50MM
• Common Device Name: VITALITY SPINAL 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: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 17890544
• Report Number: 3012447612-2023-00310
• Device Sequence Number: 7551939
• Product Code: NKB
• UDI-Device Identifier: 00889024002159
• UDI-Public: (01)00889024002159(10)W834061(11)220616
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K150896
• 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,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2023

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: 07.02000.118
• Device Lot Number: W834061
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/27/2023
• Is the Reporter a Health Professional?: Yes
• 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: 10/06/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2022
• 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: SEE H10
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic