MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. SHORT ROCKET REDUCER; VITALITY SPINAL FIXATION SYSTEM

Catalog Number	730M0024
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/26/2023
Type of Reportable Event	Serious Injury
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 foreign object was observed when the surgeon was reviewing an x-ray that was taken intra-operatively.It is believed to be the pin from a rocket reducer, but this cannot be fully determined.There are no plans to revise the patient to remove the object.
Additional Manufacturer Narrative
H6: additional method code: 4109.Corrections in d9 and h3.Additional information in h4 and h6: component, investigation type, findings, and conclusions.Device evaluation: x-rays were provided for review and used for confirming the presence of the pin post-op.The returned device matches the information in the complaint file and was examined.Visual inspection revealed that one of the pins that retains a reduction arm was missing and the device was disassembled.Root cause: root cause was unable to be determined.This event could possibly be attributed to an unknown operational event.Dhr review: the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left highridge medical¿s control.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.
Event or Problem Description
It was reported that a foreign object was observed when the surgeon was reviewing an x-ray that was taken intra-operatively.It is believed to be the pin from a rocket reducer, but this cannot be fully determined.There are no plans to revise the patient to remove the object.

• Brand Name: SHORT ROCKET REDUCER
• 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: 17398730
• Report Number: 3012447612-2023-00225
• Device Sequence Number: 20313818
• Product Code: NKB
• UDI-Device Identifier: 00887868244780
• UDI-Public: (01)00887868244780(10)MC4325503B
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K183550
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 730M0024
• Device Lot Number: MC4325503B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic