MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME CFXFEN XTAB 7X45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 186770445

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2019

Event Type  malfunction  

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 Description

(b)(6) hospital (b)(6) 2019: viper prime 7x45mm 186770445 screw was about to be inserted on patient and was not rigid, was loose and floppy.Further investigation illustrates the cocr saddle of the screw became disengaged and loose out of the tulip of the screw.Did the event occur during sterile processing? --> unknown, did the event occur during field inspection? --> unknown, did the event occur during internal service activities such as calibration? --> unknown, patient status/ outcome / consequences --> no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> unknown, is the patient part of a clinical study --> unknown,.

Manufacturer Narrative

Product complaint #: (b)(4).Udi: (b)(4).

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.Visual examination of the returned device found the saddle was completely separated from the rest of the screw.The inside of the screw's drive feature shows signs of wear, and there are nick marks on the side of the saddle.No other damage was found to the remainder of the screw.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 the root cause of the saddle being forced loose 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, 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 7X45MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8455623
• MDR Text Key: 144163310
• Report Number: 1526439-2019-51490
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034509617
• UDI-Public: (01)10705034509617
• Combination Product (y/n): N
• PMA/PMN Number: K170543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186770445
• Device Catalogue Number: 186770445
• Device Lot Number: TBTMA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Date Manufacturer Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1