MAUDE Adverse Event Report: DEPUY SPINE INC XPDM THORACIC PEDICLE PRB, ST; THORACIC PROBE, STRAIGHT

Model Number 279702030

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes rep.Without a lot number, the device history records review could not be completed as no product was received.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that a pedicle finder #279702030 broke when the surgeon was trying to create a whole/trajectory in the vertebra.Pedicle finder #279702040 bent during the same procedure while the surgeon was trying to make another whole/trajectory in a vertebra.The tip of the instrument broke inside the patient's bone but the surgeon was able to retrieve it and pull it out.Surgery completed with similar instruments taken from another set.No patient harm.This complaint involves one (1) devices.This report is 1 of 1 for (b)(4).

• Brand Name: XPDM THORACIC PEDICLE PRB, ST
• Type of Device: THORACIC PROBE, STRAIGHT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 9930386
• MDR Text Key: 225930487
• Report Number: 1526439-2020-00823
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 10705034198439
• UDI-Public: (01)10705034198439
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 279702030
• Device Catalogue Number: 279702030
• Date Manufacturer Received: 03/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1