MAUDE Adverse Event Report: DEPUY SPINE INC 5.5 VIPER UNIV POLY DRIVER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 279734000N

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

It was reported that on (b)(6) 2020, during an unknown procedure, the surgeon prepared the patient's l5 pedicle on the left side for pedicle screw placement.The surgeon tapped the prepared pathway with the 6.0mm tap and determined the appropriate screw size.The surgeon requested the 7.0x45mm screw, which the surgical tech loaded on the corresponding navigation driver.The surgeon commented on the patient's strong bone quality and suggested following the 6.0 tap with the 7.0 tap to further prepare the pathway.The surgeon determined it was not necessary and proceeded with his screw placement.As he advanced the pedicle screw down the pedicle with minimal resistance.At approximately 40-45mm into pedicle screw placement, the surgeon encountered significant resistance and on the final turn of the driver, the tip broke off in the recess of the pedicle screw.The surgeon was able to retrieve the broken tip, and he was satisfied with the position of the pedicle screw.The broken driver was removed from the sterile field and replaced with a new driver.The procedure continued without further incident.There was no surgical delay.Fragments were generated, and easily removed.There were no patient consequences.The procedure was successfully completed.Concomitant device reported: 5.5 ti cort fix 7x45mm (part# 1867-31-745, lot# unknown, quantity unknown); 6mm dual-lead tap (part# 2797-02-600n, lot# unknown, quantity unknown); 7mm dual-lead tap (part# 2797-02-700n, lot# unknown, quantity unknown).This report is for one (1) 5.5 viper univ poly driver.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.Visual inspection: the 5.5 viper univ poly driver (p/n: 279734000n, lot # gm5358811) 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 identified with the returned device.Device failure/defect identified? yes.Dimensional inspection: the outer diameter of the shaft near the broken tip was measured to be within the specification.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed: igs brainlab - quick disconnect poly driver - assembly.Igs brainlab - quick disconnect poly driver - driver sub-assembly.Igs brainlab - quick disconnect poly driver - driver shaft.Complaint confirmed? yes, the device received was broken.Hence confirming the allegation.Investigation conclusion: the complaint condition was confirmed for the 5.5 viper univ poly driver (p/n: 279734000n, lot # gm5358811).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.Device history lot: a review of the receiving inspection (ri) for 5.5 viper univ poly driver was conducted identifying that lot number gm5358811 was released in a single batch.Batch1: lot was released on jan 9, 2020 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 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: 5.5 VIPER UNIV POLY DRIVER
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10863485
• MDR Text Key: 217696410
• Report Number: 1526439-2020-02228
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10705034388410
• UDI-Public: 10705034388410
• Combination Product (y/n): N
• PMA/PMN Number: K120867
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 279734000N
• Device Catalogue Number: 279734000N
• Device Lot Number: GM5358811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/18/2020
• Supplement Dates Manufacturer Received: 11/24/2020
• Supplement Dates FDA Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 5.5 VIPER UNIV POLY DRIVER.; 6MM DUAL-LEAD TAP.; 7MM DUAL-LEAD TAP.