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 05/05/2021

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 spinal fusion surgery the fellow working along with the surgeon was inserting viper cortical fix screw with driver.Bone was very hard and the tip of the driver broke when the screw is almost fully seated into the bone.They were able to complete the construct and finished the surgery as intended.The fragment was lodged in the screw and the surgeon could not get it out and decided to leave the fragment in and there is no plans to remove to the fragment.There was no surgical delay.There were no patient consequences.The surgeon was satisfied with the screw position and completed the surgery successfully.This report is for one (1) universal navigation expedium spine system quick connect poly driver 5.5 this is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: a product investigation was conducted.Visual inspection: the 5.5 viper univ poly driver (p/n: 279734000n, lot #: gm4735201) was returned and received at us cq.Upon visual inspection, it was observed that the device was the sleeve sub assembly (lot #: gm4735201) was received assembled with the driver shaft shaft sub assembly (lot #: gm4491301).The distal tip of the driver shaft (p/n: 887034096) was observed to be broken and the broken fragment was not returned.The differences in the lot numbers between the components indicates the customer had potentially disassembled the devices for cleaning and sterilization and mixed up the components with other device components when reassembling them.The etch on the device started to fade but have no impact on the device functionality.The reported embedded device cannot be confirmed as no x-rays were provided.No other issues were observed with the returned device.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed investigation conclusion: the complaint condition was confirmed for the 5.5 viper univ poly driver (p/n: 279734000n, lot #: gm4735201).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.H3, h4, h6: a device history record (dhr) review was conducted: a review of the receiving inspection (ri) for 5.5 viper univ poly driver was conducted identifying that lot number gm4491301 was released in a single batch.Lots were released on 04 apr 2016 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.A review of the receiving inspection (ri) for 5.5 viper universal polyaxial driver was conducted identifying that the lot number gm4735201 was released in a single batch.Batch1: lot qty of (b)(4) units were released on june 19, 2017.Nr was identified but it did not contribute to the problem reported by the customer.The final quality release criteria were met before this batch was released for distribution.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 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: 11921548
• MDR Text Key: 253793370
• Report Number: 1526439-2021-01083
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10705034388410
• UDI-Public: (01)10705034388410
• Combination Product (y/n): N
• PMA/PMN Number: K140927
• 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: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• 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: GM4491301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Date Manufacturer Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN SCREWS; UNKNOWN SCREWS
• Patient Outcome(s): Required Intervention