MAUDE Adverse Event Report: DEPUY SYNTHES SPINE / MEDOS INTERNATIONAL SARL DEPUY SYNTHES THORACIC STRAIGHT PROBE PEDICLE FINDER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 279702030N

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 10/06/2021

Event Type  Injury  

Event Description

Thoracic straight probe broke while in use.Both pieces retrieved.Used a broken screw removal set to remove the working end from the patient's bone.Surgery proceeded as planned.Fda safety report id# (b)(4).

• Brand Name: DEPUY SYNTHES THORACIC STRAIGHT PROBE PEDICLE FINDER
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY SYNTHES SPINE / MEDOS INTERNATIONAL SARL; raynham MA
• MDR Report Key: 12665029
• MDR Text Key: 277878937
• Report Number: MW5104767
• Device Sequence Number: 1
• Product Code: OLO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/15/2021

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
• Device Operator: Health Professional
• Device Model Number: 279702030N
• Device Catalogue Number: 279702030N
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 119