MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME CFXFEN XTAB 6X45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	186760445
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.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
Sales rep left voicemail (b)(4) 2019 regarding product complaint.No details provided.Awaiting further information.Details provided by sales rep (b)(4) 2019: the collet came out of the viper prime screw and was not allowing the rod to seat in the head of the screw.Surgeon removed screw and retrieved collet.No fragments or associated screw components were found.New screw was placed and rod seated without difficulty.
Additional Manufacturer Narrative
Product complaint # (b)(4).Udi: (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.There were no immediately observable defects to the screw.Close examination of the saddle while handling the screw shank found that the saddle shifted a couple of millimeters while moving the shank.The saddle is intended to stay in a nearly fixed position and not have this amount of play to it.The saddle was also noted to twist slightly clockwise and counter clockwise when the saddle was pushed in the corresponding direction.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.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.The root cause of the saddle being forced loose into the tulip head cannot be determined from the sample and the information provided.A potential root cause may be excessive force placed on the screw during tightening.This may have occurred if high amounts of stress were placed on the saddle, especially at an extreme angle in relation to the adjacent components of the screw.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.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 6X45MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8339188
• Report Number: 1526439-2019-51351
• Device Sequence Number: 19396422
• Product Code: NKB
• UDI-Device Identifier: 10705034509402
• UDI-Public: (01)10705034509402
• Combination Product (Y/N): N
• PMA/510(K) Number: K170543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2019

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: 186760445
• Device Catalogue Number: 186760445
• Device Lot Number: TBWPN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 03/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1