MAUDE Adverse Event Report: DEPUY-SNYTHES SPINE DEPUY-SYNTHES SPINE; PEDICLE PROBE - LENKE

Catalog Number 03.622.005

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/28/2017

Event Type  malfunction  

Event Description

Event: break/failure of instrument used in spinal procedure.During preparation of left lumbar five vertebral body pedicle, the pedicle probe (curved lenke type - synthes green handle) broke during attempt to remove it after the pedicle path had been created.It broke at transition between the distal square shape and the more proximal round shape of the steel stem.This resulted in an approx.30 mm portion of retained metal.Despite multiple attempts to remove the retained fragment via the procedure's posterior approach, the retained portion could not be removed safely.The removable portion of the device was retained by my hospital.Serial imaging of the patient spine has not indicated migration of the device.

• Brand Name: DEPUY-SYNTHES SPINE
• Type of Device: PEDICLE PROBE - LENKE
• Manufacturer (Section D): DEPUY-SNYTHES SPINE; raynham MA 02767
• MDR Report Key: 7247357
• MDR Text Key: 99329268
• Report Number: MW5075099
• Device Sequence Number: 1
• Product Code: HXB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.622.005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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): Other
• Patient Age: 49 YR
• Patient Weight: 77