MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. ADJUSTABLE OCCIPITAL ROD, TI (3.5MM / 3.8MM X 264 MM L); VIRAGE OCT SPINAL FIXATION SYSTEM

Catalog Number	07.01711.001
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/09/2020
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 report 3012447612-2021-00006.
Event or Problem Description
It was reported two rods within their packages look to have been cut off from the full rod assembly, possibly from a previous use.This was found upon receipt so there were no surgical or patient impacts.This is report two of two for this event.
Additional Manufacturer Narrative
Additional information in h6: component, investigation type, findings, and conclusions.This follow-up report is being submitted to relay additional information.Medical records were not provided for review.Device evaluation: visual inspection of the devices reveals that the products were returned in sealed original packaging.Looking at the rods through the plastic packaging shows that they have rough edges and do not look whole.Potential cause the cause was found to be related to manufacturing per a scar.Dhr review per dhr review, the part was likely conforming when it originally left zimmer biomet control.Although this dhr shows it was conforming when it originally left zimmer biomet's control, the product came back to zimmer biomet and was repackaged and labeled erroneously.As the repackaging process creates one-off issues like this, there are no indications that other released rods have this same failure so no actions are required.Device use this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.
Event or Problem Description
It was reported two rods within their packages look to have been cut off from the full rod assembly, possibly from a previous use.This was found upon receipt so there were no surgical or patient impacts.This is report two of two for this event.

• Brand Name: ADJUSTABLE OCCIPITAL ROD, TI (3.5MM / 3.8MM X 264 MM L)
• Common Device Name: VIRAGE OCT SPINAL FIXATION SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 11127724
• Report Number: 3012447612-2021-00007
• Device Sequence Number: 689092
• Product Code: KWP
• UDI-Device Identifier: 00889024328624
• UDI-Public: (01)00889024328624(10)63347717
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K133556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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: 07.01711.001
• Device Lot Number: 63347717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1