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

Model Number	286740020
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported on (b)(6) 2021, that during an incoming inspection the loaner set department was noticed that the instrument¿s locking screws is seized up.There was no surgery and patient involvement.This complaint involves one (1) device.This report is for (1) viper3d compressor/distractor.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D9.Date device returned to manufacturer.H6 - codes updated to imdrf codes.Visual inspection: the viper3d compressor/distractor was returned and received at us cq.Visual inspection of the complaint device showed that the rotational locking screw on secondary body is jammed and cannot be loosened.However the pivoting sleeve was rotating freely and was not locked.Additionally, signs of field usage were observed on the device.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 jammed and cannot be loosened.The pivoting sleeve was unable to be locked as the jammed rotational locking screw could not be loosened or tightened.This could have caused the complaint condition.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.Investigation conclusion: the complaint condition was confirmed for the viper3d compressor/distractor.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 or debris ingress.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 compressor/distractor rack was conducted identifying that was released.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: VIPER3D COMPRESSOR/DISTRACTOR
• Common Device Name: EXTRACTOR
• 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: 13062784
• Report Number: 1526439-2021-02611
• Device Sequence Number: 1661651
• Product Code: HWB
• UDI-Device Identifier: 10705034214757
• UDI-Public: 10705034214757
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 286740020
• Device Catalogue Number: 286740020
• Device Lot Number: GM3627801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• 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: 02/07/2022
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown