MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONCORDE CLEAR 15DEG 5MM; ARTHROSCOPE

Model Number	163005630
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: reporter is a synthes employee.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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the distal tip of the concord clear device broke, all the components were retrieved.There was no surgical delay.Another device was used to complete the procedure.The surgery was completed successfully.There was no consequence to the patient.This report involves one (1) concorde clear mis discectomy device 6mm, 30 degrees.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H4, h6: a review of the receiving inspection (ri) for mis disc device 15deg 5mm was conducted identifying that lot number 65866 was released in two batches.Batch1: released on march 28, 2019 with no discrepancies.Batch2: released on april 12, 2019 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: CONCORDE CLEAR 15DEG 5MM
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11581942
• Report Number: 1526439-2021-00588
• Device Sequence Number: 4781423
• Product Code: HRX
• UDI-Device Identifier: 10705034507408
• UDI-Public: (01)10705034507408
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K122861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2021

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 Model Number: 163005630
• Device Catalogue Number: 163005515
• Device Lot Number: 65866
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 09/08/2021
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 90