MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH PRIME STYLET DEPTH ADJUSTOR; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	286750041
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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 the (b)(6) reports an event as follows: it was reported that a viper prime stylet adjuster was damaged on (b)(6) 2019, when it was being disassembled; the distal end of the adjuster has broken away.This report is for a prime stylet depth adjustor.This is report 1 of 1 for (b)(4).

• Brand Name: PRIME STYLET DEPTH ADJUSTOR
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9364298
• Report Number: 1526439-2019-52476
• Device Sequence Number: 11304387
• Product Code: OLO
• UDI-Device Identifier: 10705034507644
• UDI-Public: (01)10705034507644
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 286750041
• Device Catalogue Number: 286750041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1