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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US ULTRA AGGRESSIVE PLUS 5.0 5PK  ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

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DEPUY MITEK LLC US ULTRA AGGRESSIVE PLUS 5.0 5PK  ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE Back to Search Results
Catalog Number 283729
Device Problems Peeled/Delaminated (1454); Suction Failure (4039)
Patient Problem Not Applicable (3189)
Event Date 07/08/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Initial reporter phone number: (b)(6). (b)(4).
 
Event Description
It was reported by the affiliate via e-mail that during an arthroscopic shoulder stabilization small metal shards observed following activation of ultra aggressive plus blade. Blade was being used to excise labral tissue in oscillate mode. Settings on fms vue1 were 2500rpm oscillation and 100mmhg respectively. Fms used in inflow/outflow mode. Surgeon noted that suction wasn't responding through shaver hand piece. Later in procedure it was noted that the shaver outflow tubing was attached to the rf rather than the shaver. Shards noticed after around 30 seconds of constant activation. Shards observed around glenoid and over labrum. Cleared away by putting shaver directly onto wall suction (joint cleaned by sucking out shards systematically around glenoid space). Delay to surgery of around 5 minutes attributed to investigation time and removal of metal fragments from the joint. Additional information received by the affiliate reported an alternative product was available but not required. The affiliate also reported soft tissue debridement was completed with an rf probe and there were no known adverse effects to the patient.
 
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Brand NameULTRA AGGRESSIVE PLUS 5.0 5PK
Type of Device ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key8862282
MDR Text Key154417736
Report Number1221934-2019-57898
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K041824
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number283729
Device Lot NumberM1807006
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/26/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/28/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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