MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNIVERSAL NAVIGATION ADAPTOR; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	286755001N
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the navigation adaptors broke.The procedure was completed successfully without a surgical delay.This report is for one (1) universal navigation adaptor.This is report 2 of 2 for (b)(4).

• Brand Name: UNIVERSAL NAVIGATION ADAPTOR
• 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: 10757301
• Report Number: 1526439-2020-02059
• Device Sequence Number: 1074542
• Product Code: OLO
• UDI-Device Identifier: 10705034472225
• UDI-Public: 10705034472225
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140927
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2020

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: 286755001N
• Device Catalogue Number: 286755001N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2020
• Initial Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1