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

Model Number	163005530
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.A review of the device history record has been requested.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.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 mexico as follows: it was reported that when used in a patient, in disc space l4 l5, during suction, it was connected to the aspiration to proceed to the extraction of the nucleus pulposus disk, it was broken in the visor of the union of the diameters of the product.However, it could be still used in surgery.There were no operative complications or risk to the patient.We do not have the device since having been in contact with a patient, the device is considered contaminated and must be removed by biological controls.This complaint involves one (1) device.This report is 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.E1: phone number reported as (b)(6).H3, h6: a review of the receiving inspection (ri) for mis disc device 30deg 5mm was conducted identifying that lot number 67552 was released in a single batch.Batch1: released on may 10, 2019 with no discrepancies.Batch2: released on december 27, 2018 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.Customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the image(s) provided.The image(s) was reviewed.It was noticed that the cylindrical shaft is broken at the distal end, hence confirming the complaint condition.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A definitive assignable root cause could not be determined based on the provided information.During the investigation, no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 30DEG 5MM
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9892098
• Report Number: 1526439-2020-00796
• Device Sequence Number: 1800297
• Product Code: HRX
• UDI-Device Identifier: 10705034507378
• UDI-Public: (01)10705034507378
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K122861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2020

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 Expiration Date: 09/29/2021
• Device Model Number: 163005530
• Device Catalogue Number: 163005530
• Device Lot Number: 67552
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 04/10/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONCORDE CLEAR 30DEG 5MM