MAUDE Adverse Event Report: DEPUY SPINE INC VIPER3D COMPRESSOR/DISTRACTOR; EXTRACTOR

Model Number 286740020

Device Problems Difficult to Open or Close (2921); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Reporter is jnj employee.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that during an incoming inspection at the loaner set department at (b)(6), it was noticed that the compression instrument cannot be tightened, and the cogs are blocking.There was no surgery and patient involvement.This complaint involves two (2) devices.This report is for (1) viper3d compressor/distractor.This report is 1 of 1 (b)(4).

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.Investigation summary: background: during an incoming inspection at the loaner set department at loc umkirch it was noticed that the compression instrument cannot be tightened and the cogs are blocking.No surgery impact.No patient impact.No further information available.This complaint involves two (2) devices.Investigation flow: device interaction/functional.Visual inspection: the viper3d compressor/distractor (p/n: 286740020, lot #: gm4686901) was returned and received at us cq.Upon visual inspection, the complaint device showed that the rotational locking screw on secondary body is rotating freely and cannot be tightened to lock the pivoting sleeve.There were slight scratches were observed on the device but has no impact on the device functionality.No other issues were identified with the returned device.Functional test: during functional test, the device was able to lock/unlock and was functioning in all the three functions (d, n and c), but the rotational locking screw on secondary body is loose and was rotating freely and cannot be tightened to lock the pivoting sleeve.This could have caused the complaint condition.The complaint can be replicated with the returned device.Dimensional inspection: a dimensional inspection was not performed as the internal components were inaccessible without destruction of the device.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Viper 3d compressor/distractor assembly: dwg-887018930, rev.H/g.The complaint was confirmed, the rotational locking screw on secondary body is loose.Hence confirming the allegation.Investigation conclusion: the complaint condition of jammed/seized was confirmed for the viper3d compressor/distractor (p/n: 286740020, lot #: gm4686901).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 the damaged internal components.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 compressor/distractor rack was conducted identifying that lot number gm4989901 was released in a single batch.Batch1: lot qty of (b)(4) units were released on 19 apr 2018 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 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: VIPER3D COMPRESSOR/DISTRACTOR
• Type of Device: EXTRACTOR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11546533
• MDR Text Key: 241714065
• Report Number: 1526439-2021-00489
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10705034214757
• UDI-Public: 10705034214757
• 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
• Report Date: 02/22/2021

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: 286740020
• Device Catalogue Number: 286740020
• Device Lot Number: GM4989901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Manufacturer Received: 02/22/2021
• Initial Date FDA Received: 03/22/2021
• Supplement Dates Manufacturer Received: 04/19/2021
• Supplement Dates FDA Received: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VIPER3D COMPRESSOR/DISTRACTOR