MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME CFXFEN XTAB 7X45MM; VIPER PRIME¿

Model Number	186770445
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional pro-codes: kwp; kwq.Complainant part is expected to be returned for manufacturer review / investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.A review of the device history record has been requested.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 the surgeon started inserting 7 x 45 mm screw into pedicle with 5 mm of stylet advanced.After tapping screwdriver over the stylet, the screw kept skiving off and the screw became loose, and not holding its trajectory.Upon closer investigation it looked like the cocr saddle had become loose.Both screwdriver and screw are available for collection.This is a consignment viper prime screwdriver and viper prime 7 x 45 mm screw.Both need replacing immediately to buderim private consignment kit.Expedium thoracic probes, straight were opened on consignment and loan trays, both were bent and needed to be replaced.All items have been tagged.Surgery was delayed 10 minutes due to the reported event.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).
Additional 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.Visual inspection of the complaint device showed that the tulip head, bushing, and sleeve have separated from the screw shank, allowing it to spin freely with no resistance.In addition, the bottom tip is broken.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.While a definitive root cause could not be determined, it is possible that the device might have encountered unintended forces.No product design or manufacturing issues were identified, and no new malfunctions were identified either.Based upon these results, 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.
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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 CFXFEN XTAB 7X45MM
• Common Device Name: VIPER PRIME¿
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9416713
• Report Number: 1526439-2019-52584
• Device Sequence Number: 18966232
• Product Code: NKB
• UDI-Device Identifier: 10705034509617
• UDI-Public: (01)10705034509617
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K170543
• 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): 11/13/2019

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: 186770445
• Device Catalogue Number: 186770445
• Device Lot Number: NW153808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 01/06/2020; 01/08/2020
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 01/06/2020; 01/24/2020
• Patient Sequence Number: 1