MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER2 T20 HEXLOBE DRIVER SHAF; DRIVER, PROSTHESIS

Model Number	286725020
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # ((b)(4).Complainant part is not expected to be returned for manufacturer review/ investigation.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 conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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 europe reports an event in (b)(6) as follows: it was reported that this was a lumbar interbody fusion at l5 treating lumbar spinal canal stenosis on (b)(6), 2021.The screw proceeded deeper than expected, the surgeon tried to put it back when the screwdrivers tip broke.According to the surgeons comment, the bone had been hardened, and the screw was tightly fixated, so, he decided not to extract both the screw and screwdrivers fragment.The procedure was completed less than 30-minute surgical delay.No further information is available.This complaint involves two (2) devices.This report is for one (1) viper2 t20 hexlobe driver shaf.This report is 1 of 2 for (b)(4).

• Brand Name: VIPER2 T20 HEXLOBE DRIVER SHAF
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11970399
• Report Number: 1526439-2021-01203
• Device Sequence Number: 4366854
• Product Code: HWR
• UDI-Device Identifier: 10705034214290
• UDI-Public: (01)10705034214290
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 286725020
• Device Catalogue Number: 286725020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention