MAUDE Adverse Event Report: DEPUY SPINE INC 1.45MM NITINOL GUIDEWIRE BLUNT; MISC ORTHO SURGICAL INSTR

Model Number	286705320
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: reporter is a (b)(6).The device was 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 or Problem Description
It was reported that on an unknown date, during a procedure, while tapping a pedicle during an mis case, the guidewire was up against the endplate.The surgeon followed the nitinol guidewire with a 6.0 tap and the tip of the tap cut through the distal tip of the guidewire as it engaged the endplate.The tap was removed, and the screw was inserted.Then the guidewire was removed, and it was noted that there was a small fragment of the guidewire in the vertebral body.Guidewire removed from field, no further issues.There was no surgical delay.There were no patient consequences.The procedure was successfully completed.Concomitant device reported.Unknown screw (part# unknown, lot# unknown, quantity unknown), unknown endplate (part# unknown, lot# unknown, quantity unknown).This complaint involves two (2) devices.This report is for (1) 1.45mm nitinol guidewire blunt.This report is 1 of 1 for (b)(4).
Event or Problem Description
It was reported that on an unknown date, during a procedure, while tapping a pedicle during an mis case, the guidewire was up against the endplate.The surgeon followed the nitinol guidewire with a 6.0 tap and the tip of the tap cut through the distal tip of the guidewire as it engaged the endplate.The tap was removed, and the screw was inserted.Then the guidewire was removed, and it was noted that there was a small fragment of the guidewire in the vertebral body.Guidewire removed from field, no further issues.There was no surgical delay.There were no patient consequences.The procedure was successfully completed.Concomitant device reported.Unknown screw (part# unknown, lot# unknown, quantity unknown), unknown endplate (part# unknown, lot# unknown, quantity unknown).This complaint involves two (2) devices.This report is for (1) 1.45mm nitinol guidewire blunt.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: reporter is a j&j representative.The device was 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.
Additional 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.H10 additional narrative: visual inspection: the 1.45mm nitinol guidewire blunt (part# 286705320, lot# gm5815216) was returned and received at us cq.Upon visual inspection, it is observed that the threaded tip of the device is partially broken and the broken fragment was not returned.No other issues were noted with the returned device.Dimensional inspection: the diameter of the device proximal to the threaded portion measured to be 1.46 mm (ca122p).This is within the specification of 1.45 mm +0.05 /- 0 mm as per the drawing 103255795 rev a.Document/specification review: the following drawings (current and manufactured to) were reviewed.No design issues or manufacturing discrepancies were noted.Investigation conclusion: the complaint is confirmed for the returned device.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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.Device history lot - a review of the receiving inspection (ri) for 1.45mm niti guidewire blunt was conducted identifying that lot number gm5815216 was released in a single batch.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 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: 1.45MM NITINOL GUIDEWIRE BLUNT
• Common Device Name: MISC ORTHO SURGICAL INSTR
• 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: 13080314
• Report Number: 1526439-2021-02619
• Device Sequence Number: 4153216
• Product Code: LXH
• UDI-Device Identifier: 10705034507859
• UDI-Public: 10705034507859
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 286705320
• Device Catalogue Number: 286705320
• Device Lot Number: GM5815216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/24/2021
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 12/23/2021
• Supplement Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN ENDPLATE; UNKNOWN SCREWS; UNKNOWN TAPS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown