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

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.

• Brand Name: CONCORDE CLEAR 30DEG 5MM
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL 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 Key: 8180811
• MDR Text Key: 131386012
• Report Number: 1526439-2018-51158
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10705034507378
• UDI-Public: (01)10705034507378
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K122861
• Number of Events Reported: 1
• 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 Number: 163005530
• Device Lot Number: QV5478PQ03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1