MAUDE Adverse Event Report: DEPUY SPINE INC VIPER PRIME STYLET; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	286750200S
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2020
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.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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent for a pps (percutaneous pedicle screw fixation) procedure.During the procedure, when olif was applied in l3-l4, two stylets bent in the patient bone.The procedure was completed successfully with 30 minutes delay.The patient status was stable.Concomitant device reported: unknown screws (part# unknown, lot# unknown, quantity unknown); unknown rod (part# unknown, lot# unknown, quantity unknown); unknown setscrews (part# unknown, lot# unknown, quantity unknown).This complaint involves two (2) devices.This report is for (1) viper prime stylet.This is report 2 of 2 for (b)(4).
Event or Problem Description
Corrected information: it was reported that the patient underwent for a percutaneous pedicle screw (pps) fixation procedure on (b)(6) 2020 as mentioned in initial report.Additional information: the procedure was completed successfully with replacement devices.
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.H10 additional narrative: b5: additional information.E1: added phone number.H4.H11 corrected data: b5: corrected information.E1; e3.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.H3, h6: investigation summary: investigation flow: visual.Visual inspection: the viper prime stylet (part # 286750200s/ lot # si5424403) was received at us cq.Upon visual inspection there were no defects found on the device.Device failure/defect identified? no.It is conclusive that the device has no defect.Document review: all relevant drawings were reviewed capturing the current & manufactured revisions.Conclusion: the overall complaint was not confirmed for the received viper prime stylet.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the investigation.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 viper prime stylet was conducted identifying that lot number si5424403 was released in a single batch.Batch1: lot qty of (b)(4) units were released on apr 24, 2019 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 STYLET
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10376068
• Report Number: 1526439-2020-01443
• Device Sequence Number: 11536220
• Product Code: NKB
• UDI-Device Identifier: 10705034507811
• UDI-Public: (01)10705034507811
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2020

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 Expiration Date: 02/29/2024
• Device Model Number: 286750200S
• Device Catalogue Number: 286750200S
• Device Lot Number: SI5424403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 09/01/2020; 09/10/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 09/09/2020; 09/21/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS; UNKNOWN SCREWS; UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS; UNKNOWN SCREWS
• Patient Age: 48 YR