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

Model Number 279702030

Device Problem Break (1069)

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

Event Date 11/11/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number, the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective, and/or 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 on (b)(6) 2020, a patient with a hard bone underwent a lumbar fusion procedure using the expedium system.During the procedure three (3) instruments were impacted.The pedicle probe broke inside the patient as the surgeon was maletting the probe inside the pedicle.The broken piece was retrieved.Then upon inserting a 9.0x80mm expedium screw inside the pelvis (illium), the ratchet on the screwdriver broke into 2 pieces and finally, the torque drive was stripped due to set screw tightening.No implants were damaged.The patient was not impacted, and there was no surgical delay.The surgery was successfully completed with other instruments present in the system.Concomitant device reported: unknown impaction instrument (part# unknown, lot# unknown, quantity 1) this report is for one (1) xpdm thoracic pedicle prb, st this is report 1 of 3 for complaint: (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: a product investigation was conducted.Visual inspection: the xpdm throracic pedicle prb,st (p/n: 279702030, lot #: nw212641) was returned and received at us cq.Upon visual inspection, it was observed that the distal tip was broken and the broken fragment was returned.No other issues were observed with the returned device.Dimensional inspection: the outer diameter of the probe near section d-d was measured and is within the specification per relevant drawing.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed investigation conclusion: the complaint condition is confirmed for the xpdm throracic pedicle prb,st (p/n: 279702030, lot #: nw212641).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.The potential cause could be due to unintended forces applied to the device.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.H3, h4, h6: a device history record (dhr) review was conducted: a review of the receiving inspection (ri) for xpdm thoracic pedicle prb, st was conducted identifying that lot number nw212641 was released in a single batch.Batch1: lot qty of (b)(4) units were released on 09 may 2018 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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.

• Brand Name: XPDM THORACIC PEDICLE PRB, ST
• Type of Device: PROBE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10979568
• MDR Text Key: 220707218
• Report Number: 1526439-2020-02382
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 10705034198439
• UDI-Public: (01)10705034198439
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• 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
• Device Lot Number: NW212641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Date Manufacturer Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN IMPACTION INSTRUMENTS