Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US ULTRA AGGRESSIVE PLUS 4.0MM 5PK; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY MITEK LLC US ULTRA AGGRESSIVE PLUS 4.0MM 5PK; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE Back to Search Results
Model Number 283429
Device Problem Break (1069)
Patient Problem Not Applicable (3189)
Event Date 01/23/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).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.Subsequent follow-up with the customer, additional information was received.It was reported that the event occurred during knee arthroscopy surgical procedure.It was reported that there were 15 blades involved in the event with two that are missing.Therefore, this is report 1 of 15 for the same event.It was reported that there was a delay of five minutes.It was reported that there were no patient consequences or impact to the user or patient.It was reported that the surgery was completed by changing the blade.It was reported that there were metallic deposits at the start of the surgery.It was reported that an alternative product was readily available.It was reported that there was no surgical intervention planned (e.G.X-rays, additional/change in procedures, prescriptions, otc, revisions).It was reported that the fragments were easily removed without additional intervention by washing the joint.Udi: (b)(4).
 
Event Description
This is report 8 of 15 for the same event.It was reported by the affiliate in (b)(6) that during a knee arthroscopy surgical procedure, it was observed that 15 ultra aggressive plus 4.0mm 5pk devices had metallic debris/deposits at the start of the surgery.As a result, there was a delay of five minutes as an alternative product was readily available to complete the procedure.It was reported that the surgery was completed by changing the blade.The fragments were easily removed without additional intervention by washing the joint.There were no patient consequences or impact to the user or patient.There was no surgical intervention planned (e.G.X-rays, additional/change in procedures, prescriptions, otc, revisions).
 
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.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: d10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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.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: according to the information provided, it was reported that during an unknown procedure the ultra aggressive plus 4.0mm 5pk had metallic debris.The complaint devices were received and evaluated.Visual observations confirm that the ultra aggressive blade plus devices were received in its original packaging and sealed, therefore the sterilization is not compromised.Only slight damages were observed in the boxes than can be attributed during handling or transportation.In addition, two packages were opened to ensure our inspection and metallic debris were not observed inside the boxes or in the blades.We cannot confirm this complaint or discern a root cause for the user to have experienced this issue.The possible root cause for the reported failure can be attributed to interaction between two devices that cannot rotate freely.However; this cannot be conclusive determined.A manufacturing record evaluation was performed for the finished device lot/serial number (b)(6), and no non-conformances were identified at this point in time, no corrective action is required and no further action is warranted.However, depuy synthes 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 lot: a manufacturing record evaluation was performed for the finished device lot/serial number (b)(6) and no non-conformances were identified.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ULTRA AGGRESSIVE PLUS 4.0MM 5PK
Type of Device
ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key9729317
MDR Text Key207593686
Report Number1221934-2020-00608
Device Sequence Number1
Product Code HRX
UDI-Device Identifier10886705022229
UDI-Public10886705022229
Combination Product (y/n)N
PMA/PMN Number
K041824
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 01/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number283429
Device Catalogue Number283429
Device Lot NumberM1905040
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/20/2020
Date Manufacturer Received03/27/2020
Patient Sequence Number1
-
-