MAUDE Adverse Event Report: DEPUY SYNTHES SPINE EXPEDIUM; PROBE

Model Number 299704115

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/04/2017

Event Type  malfunction  

Manufacturer Narrative

A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device not returned for evaluation.

Event Description

L5/s1 plif.While using 299704115 to create the s1 (right side) pedicle screw trajectory the probe was inserted by hand and then advanced with a mallet.It was then rotated in the patient and the tip snapped off.The tip still remains in the patients sacrum as the surgeon deemed it to difficult to retrieve.The 299704105 was then used instead and the procedure was completed to the surgeons satisfaction.2 minute delay to procedure.Ae to patient: part of 299704115 remains in the patients sacrum.'product discarded' has been selected for product status in this instance as there is no appropriate status available to represent the following local process: instrument will be sent to local engineering for assessment of wear and tear.If 'wear and tear' is assigned, a copy of the local assessment will be provided to the manufacturer for their record and case closure.In the case wear and tear cannot be assigned by the engineer, the product will be returned to the manufacturer as a 'product complaint' for investigation.

• Brand Name: EXPEDIUM
• Type of Device: PROBE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6894918
• MDR Text Key: 88236699
• Report Number: 1526439-2017-10762
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 10705034467238
• UDI-Public: (01)10705034467238
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 299704115
• Device Catalogue Number: 299704115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31 YR