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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH CONCORDE CLEAR 30DEG 5MM; ARTHROSCOPE

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MEDOS INTERNATIONAL SàRL CH CONCORDE CLEAR 30DEG 5MM; ARTHROSCOPE Back to Search Results
Catalog Number 163005530
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The concorde clear 30deg 5mm was not returned to the customer quality unit for evaluation.A device history record review did not identify any issues that may have caused or contributed to the reported event.Without the return of the concorde clear 30deg 5mm we are unable to confirm the reported issue or identify the root cause.As no issues were identified during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Therefore, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported that the concorde clear tip broke off.Patient consequence? :no.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.
 
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Brand Name
CONCORDE CLEAR 30DEG 5MM
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ  02400
Manufacturer (Section G)
MEDOS INT SPINE
chemin blanc 38
le locle
SZ  
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key8180811
MDR Text Key131386012
Report Number1526439-2018-51158
Device Sequence Number1
Product Code HRX
UDI-Device Identifier10705034507378
UDI-Public(01)10705034507378
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K122861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 11/29/2018
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
Device Operator Health Professional
Device Catalogue Number163005530
Device Lot NumberQV5478PQ03
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/29/2018
Initial Date FDA Received12/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/07/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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