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

Catalog Number 730M0024

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2023

Event Type  malfunction  

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 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.

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 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
• 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 Key: 18162751
• MDR Text Key: 328431409
• Report Number: 3012447612-2023-00354
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887868244780
• UDI-Public: (01)00887868244780(10)MC4395804
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K183550
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/16/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 730M0024
• Device Lot Number: MC4395804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic