MAUDE Adverse Event Report: DEPUY SPINE INC VIPER PRIME NAV SHAFT ASSY; ORTHOPAEDIC STEREOTAXIC INSTRU

Model Number	286750131N
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is jnj representative.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.
Event or Problem Description
Device report from (b)(6) reports an event as follows: it was reported on (b)(6) 2020, that the patient underwent for an unknown procedure.It was discovered that the tip of the inserter shaft was wobbly.It was unknown if the procedure completed successfully.The patient condition was reported stable.Concomitant device reported: unknown screw (part# unknown, lot# unknown, quantity unknown).This complaint involves one (1) device.This report is for (1) viper prime nav shaft assy this report is 1 of 1 for pc (b)(4).
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.H10 additional narrative: h3, h6: investigation summary: the product was returned to us cq for evaluation.The us cq conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the device except normal wear which would not contribute to the reported complaint condition.The functional test cannot be performed on the returned device as no mating devices were returned for the evaluation.As part of depuy spine¿s quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the viper prime nav shaft assy was returned without detectable damage.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.The complaint was not confirmed as no visual damages were observed on the returned device.No definitive root cause can be determined.There was no indication that a design or manufacturing issue contributed to the complaint.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.Dimensional inspection: the dimensional inspection was not performed as no damages were observed on the device which would contribute to the alleged device interaction issue.Document/specification review: the relevant drawings are reflecting the current and manufactured revisions were reviewed: device history lot: a review of the receiving inspection (ri) for viper prime nav shaft assy was conducted identifying that lot number mf4331201was released in a single batch.Batch1: lot qty of (b)(4) units were released on nov 19, 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 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: VIPER PRIME NAV SHAFT ASSY
• Common Device Name: ORTHOPAEDIC STEREOTAXIC INSTRU
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11067672
• Report Number: 1526439-2020-02477
• Device Sequence Number: 846692
• Product Code: OLO
• UDI-Device Identifier: 10705034507781
• UDI-Public: 10705034507781
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170937
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2020

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
• Operator of Device: Health Professional
• Device Model Number: 286750131N
• Device Catalogue Number: 286750131N
• Device Lot Number: MF4331201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Initial Date Received by Manufacturer: 11/26/2020
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 02/01/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SCREWS