MAUDE Adverse Event Report: DEPUY SPINE INC VIPER2 SCREW EXT, MULTI PIECE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	286725225
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2020
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.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 during minimally invasive spinal fusion procedure performed on (b)(6) 2020, the viper 2 tower failed to grip onto the tulip of the screw and came off during the surgery.It was replaced with another one.There was surgical delay of five (5) minutes.The procedure was successfully completed.No patient consequences reported.Concomitant device reported: unknown screws (part# unknown, lot# unknown, quantity unknown ).This report is for one (1) viper2 screw ext, multi piece.This is report 1 of 8 for (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: d4: lot number and expiration date updated.G1: physical manufacturer updated.H3, h6: 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.
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.H3, h6: a product investigation was conducted.Visual inspection: viper2 screw ext, multi piece (part# 286725225, lot# mi65851, qty:(b)(4)) was returned and received at us cq.Upon visual inspection at cq, it is observed that there was no physical damage with the device.The surface of the device shows normal wear consistent with the device use which would not contribute to the complaint condition.Functional testing: functional testing of the received device was not performed at cq as the device was received by itself.Dimensional inspection: dimensional inspection of the received device was not performed at cq as the relevant internal features of the device were inaccessible.Documentation/ specification review: the relevant drawing(s) was reviewed: no design issues or discrepancies were found during this investigation.Investigation conclusion: the complaint cannot be confirmed for viper2 screw ext, multi piece (part# 286725225, lot# mi65851) as the functional test cannot be performed at cq to replicate the reported unable to assemble issue.A definitive root cause could not be identified for the reported problem.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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 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.H10 additional narrative: h3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device history lot a review of the receiving inspection (ri) for viper2 screw ext, multi piece was conducted identifying that lot number mi65851 was released in a single batch.Batch1: lot qty of (b)(4) units were released on june 06, 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 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: VIPER2 SCREW EXT, MULTI PIECE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10690571
• Report Number: 1526439-2020-01969
• Device Sequence Number: 19648128
• Product Code: LXH
• UDI-Device Identifier: 10705034214320
• UDI-Public: (01)10705034214320
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/24/2020

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: 286725225
• Device Catalogue Number: 286725225
• Device Lot Number: MI65851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 10/21/2020; 11/04/2020; 11/04/2020
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 11/04/2020; 11/05/2020; 12/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SCREWS; UNKNOWN SCREWS