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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
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 intra-op during the derotation procedure, a vital rocket reducer was damaged.One of the two blocking pins was pulled off.The procedure was completed without harm to patient using other rocket reducers.
Additional Manufacturer Narrative
H3: "device evaluation anticipated, but not yet begun" is erroneous and no longer applies.The device was evaluated.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 one of the pins connecting the arm to the body has disassembled from the device.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.Dhr review: per dhr review, the part was likely conforming when it left highridge 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 intra-op during the derotation procedure, a vital rocket reducer was damaged.One of the two blocking pins was pulled off.The procedure was completed without harm to patient using other rocket reducers.

• 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: 18162751
• Report Number: 3012447612-2023-00354
• Device Sequence Number: 7275176
• Product Code: NKB
• UDI-Device Identifier: 00887868244780
• UDI-Public: (01)00887868244780(10)MC4395804
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K183550
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2024

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: 730M0024
• Device Lot Number: MC4395804
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/02/2023
• 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: 11/17/2023
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2020
• 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
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic