MAUDE Adverse Event Report: DEPUY SPINE INC CANNULATED PEDICLE PROBE

Model Number 286710116

Device Problems Break (1069); Material Deformation (2976); Material Twisted/Bent (2981)

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

Event Type  malfunction  

Manufacturer Narrative

Occupation: reporter is a j&j employee.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 the tips of the cannulated pedicle probes are worn and cracked.The inner awl is blunted from use.One of the probes are also visibly bent.These are seemingly a result of wear-and-tear.There was no patient involvement.This report is for one (1) cannulated pedicle probe.This is report 2 of 2 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.Investigation flow: damage.Visual inspection: the cannulated pedicle probe (part #: 286710116 and lot #: mi41800) was received at us cq.Upon visual inspection, the stylet (component #: 887030608) was observed to be stripped and slightly broken at its distal end.Also, the stylet was seen to be bent.No other issues were identified with the returned device.Device failure/defect was identified.Dimensional inspection: the dimensional inspection of the received device could not be conducted due to post-manufacturing damage.Complaint was confirmed.Conclusion: the complaint was confirmed for the cannulated pedicle probe.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces during its use.No new malfunctions were observed during this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot: a review of the receiving inspection (ri) for cannulated pedicle probe was conducted identifying that lot number mi41800 was released in a single batch.Batch1: lot qty of (b)(4) units were released on june 30, 2015 with no discrepancies.Device history review: 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: CANNULATED PEDICLE PROBE
• Type of Device: PROBE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10922505
• MDR Text Key: 220315351
• Report Number: 1526439-2020-02315
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 10705034213828
• UDI-Public: (01)10705034213828
• 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: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 286710116
• Device Catalogue Number: 286710116
• Device Lot Number: MI41800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Date Manufacturer Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1