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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH 3.0MM STD THREAD NAV TAP ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MEDOS INTERNATIONAL SàRL CH 3.0MM STD THREAD NAV TAP ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 3010-19-028
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/17/2021
Event Type  malfunction  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Reporter is a j&j sales representative. 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 Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that during a procedure on (b)(6), 2021, the drill guide adaptor broke. No fragments were generated. The procedure was successfully completed with no surgical delay. There was no patient consequence. This report is for one (1) 3. 0mm std thread nav tap. This is report 4 of 4 for complaint (b)(4).
 
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Brand Name3.0MM STD THREAD NAV TAP
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key13238327
MDR Text Key289776156
Report Number1526439-2022-00086
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K200791
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/12/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3010-19-028
Device Catalogue Number301019028
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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