MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME T-HANDLE; ORTHOPAEDIC STEREOTAXIC INSTRUMENT

Model Number	286750035
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Investigation summary: the complaint device was not received for investigation.The following investigation is based on the image(s) provided in the attachment(s).The images were reviewed, and the complaint condition can be confirmed as the received image shows clear breakage of viper prime t-handle.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 during a posterior spinal fusion on (b)(6) 2020 a viper t-handle broke and the insertion instrument became bent.The surgeon used a viper prime screw driver to insert the screw.As the surgeon backed the driver out once the screw was in the pedicle, the stylet bent making it hard to back out the driver.The surgeon then used mallet force on the black t-handle to knock it out and snapped the handle into three part.No fragments remained in the patient.The procedure was successfully completed with another handle.No surgical delay was reported.Concomitant device reported: unknown screwdriver (part# unknown, lot# unknown, quantity 1), unknown distractor (part# unknown, lot# unknown, quantity unknown), unknown screw (part# unknown, lot# unknown, quantity unknown).This is report 1 of 2 for (b)(4).

• Brand Name: VIPER PRIME T-HANDLE
• Common Device Name: ORTHOPAEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10413092
• Report Number: 1526439-2020-01482
• Device Sequence Number: 14064751
• Product Code: OLO
• UDI-Device Identifier: 10705034507620
• UDI-Public: (01)10705034507620
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K170937
• 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
• Report Date (Section B): 07/23/2020

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: 286750035
• Device Catalogue Number: 286750035
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 08/17/2020
• 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 INSERTION INSTRUMENTS; UNKNOWN SCREWDRIVERS; UNKNOWN SCREWS