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

Catalog Number	163005530
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8180811
• Report Number: 1526439-2018-51158
• Device Sequence Number: 1098699
• Product Code: HRX
• UDI-Device Identifier: 10705034507378
• UDI-Public: (01)10705034507378
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K122861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 163005530
• Device Lot Number: QV5478PQ03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1