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

Model Number 279734000N

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/20/2022

Event Type  Injury  

Manufacturer Narrative

The subject 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

It was reported that on (b)(6) 2021 during posterior spinal fusion procedure, while placing a viper xtab screw in lumbar pedicles l5 and l4.The tips of both kick 2d brainlab screwdrivers sheared off.Attempt was made to remove sheared off tips but both were embedded inside the internal hex of the screw.Rod could lay flush and tighten down completely so surgeon made decision to leave the screws in as patient had hard bone and surgeon did not want to risk fracturing a pedicle while trying to remove.There was a surgical delay of thirty (30) minutes.The procedure was successfully completed.This report is for one (1) 5.5 viper univ poly driver.This is report 1 of 2 for complaint (b)(4).

Event Description

It was reported that on (b)(6) 2021 during posterior spinal fusion procedure, while placing a viper xtab screw in lumbar pedicles l5 and l4.The tips of both kick 2d brainlab screwdrivers sheared off.Attempt was made to remove sheared off tips but both were embedded inside the internal hex of the screw.Rod could lay flush and tighten down completely so surgeon made decision to leave the screws in as patient had hard bone and surgeon did not want to risk fracturing a pedicle while trying to remove.There was a surgical delay of thirty (30) minutes.The procedure was successfully completed.This report is for one (1) 5.5 viper univ poly driver.This is report 1 of 2 for complaint (b)(4).

Manufacturer Narrative

The subject 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.

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.H3, h6: a review of the receiving inspection (ri) for 5.5 viper univ poly driver was conducted identifying that lot number gm5596505 was released in a single batch.Batch1: lot qty of (b)(4) units were released on aug 3, 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.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the 5.5 viper univ poly driver was broken.The distal tip of the device was broken off and the broken off portion was not returned.There was also evidence of corrosion on the device.No other defects were noted.Images were reviewed and no additional defects were found.No evidence was provided of any embedded devices, therefore that condition cannot be confirmed.A dimensional inspection was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the 5.5 viper univ poly driver would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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 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
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13559569
• MDR Text Key: 285821239
• Report Number: 1526439-2022-00245
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10705034388410
• UDI-Public: (01)10705034388410
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140927
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• 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

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 279734000N
• Device Catalogue Number: 279734000N
• Device Lot Number: GM5596505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - MONO/POLYAXIAL SCREWS: VIPER; UNK - RODS: VIPER
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male