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 12/08/2020

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 during an unknown procedure on (b)(6) 2020, the tips of both expedium thoracic pedicle probe got damaged, one broke and the other got bent.The surgery was completed with another similar instrument.No patient consequences reported.No further information provided.This report is for one (1) xpdm thoracic pedicle prb, st.This is report 1 of 1 for (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.The instrument(s) was not returned, and the investigation will be completed based on the supplied image(s) from the attachment(s) located in notes & attachments section of the product complaint.The image(s) was reviewed, and the complaint condition of broken tip was confirmed as the image(s) showed tip broken.As the instrument(s) was not returned and as received, dimensional, material or drawing reviews are not applicable.A manufacturing record evaluation was not performed as the lot number could not be determined from the image there is no indication that a design or manufacturing issue contributed to the complaint as the circumstances during the time of the event are unknown.No new malfunctions were observed during this investigation (based on the images) that may have contributed to the complaint condition.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.A manufacturing record evaluation was not performed as the lot number could not be determined from the image.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.

Manufacturer Narrative

Product complaint #(b)(4).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.D11: additional concomitant device reported: investigation summary the tips of both instruments got damaged during surgery.One broke and the other got bent.No incident to report.Surgery completed with another similar instrument.Disclosed.If any new information will be made available, the additional information will be submitted through cst.True.This complaint involves two (2) devices.Customer quality investigation: the instrument(s) was not returned, and the investigation will be completed based on the supplied image(s) from the attachment(s) located in notes & attachments section of the product complaint.The image(s) was reviewed, and the complaint condition of broken tip was confirmed as the image(s) showed tip broken.As the instrument(s) was not returned and as received, dimensional, material or drawing reviews are not applicable.A manufacturing record evaluation was not performed as the lot number could not be determined from the image.There is no indication that a design or manufacturing issue contributed to the complaint as the circumstances during the time of the event are unknown.No new malfunctions were observed during this investigation (based on the images) that may have contributed to the complaint condition.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.Background: the tips of both instruments got damaged during surgery.One broke and the other got bent.No incident to report.Surgery completed with another similar instrument.No charge replacements will be needed.This complaint involves two (2) devices.Investigation flow: damage.Visual inspection: the xpdm thoracic pedicle prb, st (p/n: 279702030, lot #: nw137216) was returned and received at us cq.Upon visual inspection, it was observed that the distal tip of the device was broken.There were scratches on the device but have no impact on the device functionality.No other issues were observed with the returned device.Device failure/defect was identified dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Expedium - pedicle probe assemblies: dwg-2797-02-010/040, rev l/h.Complaint was confirmed.The device received was broken.Hence confirming the allegation.Investigation conclusion the complaint condition is confirmed for the xpdm thoracic pedicle prb, st (p/n: 279702030, lot #: nw137216).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.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: device history lot a review of the receiving inspection (ri) for xpdm thoracic pedicle prb, st was conducted identifying that lot number nw137216 was released in a single batch.Batch1: lot qty of (b)(4) units were released on 27 jul 2013 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 history batch null, device history review a manufacturing record evaluation was not performed as the lot number could not be determined from the image, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.H11/ d4: lot number provided for reporting.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: 11126060
• MDR Text Key: 226854932
• Report Number: 1526439-2021-00098
• 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,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• 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: NW137216
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: XPDM THORACIC PEDICLE PRB, ST; XPDM THORACIC PEDICLE PRB, ST