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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH THORACIC STRAIGHT PROBE ORTHOPAEDIC STEREOTAXIC INSTRUMENT

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MEDOS INTERNATIONAL SàRL CH THORACIC STRAIGHT PROBE ORTHOPAEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 279702030N
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/17/2021
Event Type  Injury  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 (b)(4) reports an event as follows: during a case on (b)(6) 2021, it was reported that four centimeters (4 cm) of the tip of the instrument broke off inside the patient¿s hard bone and was un-retrievable. The procedure was completed with no delay. The patient reportedly went home the next day and is doing well. There is no plan to remove the broken part in the future. This report is for a thoracic straight probe. This is report 1 of 1 for (b)(4).
 
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Brand NameTHORACIC STRAIGHT PROBE
Type of DeviceORTHOPAEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer (Section G)
SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC)
50461 west pontiac trail
wixom MI 48393
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key12468059
MDR Text Key271286105
Report Number1526439-2021-01991
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
PMA/PMN Number
K140927
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 08/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number279702030N
Device Catalogue Number279702030N
Device Lot NumberGM5335701
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/07/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/14/2021 Patient Sequence Number: 1
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