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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. TOP LOADING POLY SCREW ASSEMBLIES 7.5X50MM; VITALITY SPINAL FIXATION SYSTEM
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ZIMMER BIOMET SPINE, INC. TOP LOADING POLY SCREW ASSEMBLIES 7.5X50MM; VITALITY SPINAL FIXATION SYSTEM Back to Search Results
Catalog Number 07.02000.118
Device Problem Inaccurate Information (4051)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported the length of the size laser marked on seven vitality screws 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 in a warehouse and did not have any patient involvement.This is report three of seven for this event.
 
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.
 
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 3012447612-2023-00325 through 3012447612-2023-00331.
 
Event Description
It was reported the length of the size laser marked on seven vitality screws 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 in a warehouse and did not have any patient involvement.This is report three of seven for this event.
 
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Brand Name
TOP LOADING POLY SCREW ASSEMBLIES 7.5X50MM
Type of Device
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 Key17942350
MDR Text Key325759515
Report Number3012447612-2023-00327
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00889024002159
UDI-Public(01)00889024002159(10)W834061(11)220616
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K150896
Exemption Number5645646
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Non-Healthcare Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 12/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number07.02000.118
Device Lot NumberW834061
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer09/27/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/15/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberSEE H10
Patient Sequence Number1
Patient SexPrefer Not To Disclose
Patient EthnicityNon Hispanic
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