MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CRVD ULT AGG BLADE 4.2MM 5PK; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Model Number	283422
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is company representative.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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)(4) as follows: it was reported that the shaver broke intraoperatively on (b)(6) 2019.In order to get the shaver in the right angle, he had to apply some pressure.No parts fell into the patient.The procedure was extended for about 2 minutes.No patient consequence.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.H10 additional narrative: investigation summary the device was received for evaluation.Visual inspection confirms that the distal end of the inner blade is broken off.Further inspection reveals that the shaft of the outer blade is bent in three different directions.The bends are in the section of the outer blade that should not be bent.The probable root cause is that an excessive lateral force was applied to the blade which caused the serrated section of the inner blade to break off.This complaint can be confirmed.A manufacturing record evaluation was performed for the finished device lot/serial number 4l28568, and no non-conformances were identified.No further information regarding the cause of the defect has been provided to help determine the actual root cause for this failure.At this point in time, no corrective action is required, and no further action is warranted.However, depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Device history lota manufacturing record evaluation was performed for the finished device lot/serial number 4l28568, and no non-conformances were identified.

• Brand Name: CRVD ULT AGG BLADE 4.2MM 5PK
• Common Device Name: ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9291659
• Report Number: 1221934-2019-59460
• Device Sequence Number: 16734907
• Product Code: HRX
• UDI-Device Identifier: 10886705025909
• UDI-Public: (01)10886705025909
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K041824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2019

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: 06/30/2020
• Device Model Number: 283422
• Device Catalogue Number: 283422
• Device Lot Number: 4L28568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 01/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1