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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK OMNICUT 5.2 (USED W/ MICRO HANDPIECE) MITEK FMS BLADES & BURRS

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DEPUY MITEK OMNICUT 5.2 (USED W/ MICRO HANDPIECE) MITEK FMS BLADES & BURRS Back to Search Results
Catalog Number 283346
Device Problem Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 02/06/2017
Event Type  Injury  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4). The lot expiration date is currently unavailable.
 
Event Description
On using onmicut blade, metal shavings broken off into shoulder joint additional information received via email from the affiliate on 2-21-2017. What type of procedure was this? arthroscopic subacromial decompression were all the shavings removed from the patient? all visible shavings were removed what was used to remove the shavings? suction did this delay the procedure, and if so how long? five to 10 minutes.
 
Manufacturer Narrative
The complaint device was received and evaluated. When observed under magnification, the inner shaft showed signs of friction between the two shafts. The friction marks indicate excessive force, which could lead to metal shavings as reported, confirming the complaint. A possible root cause would be improper use of blade/bur such as too much force, speed, blade/bur selection on tissue type. A dhr review has been conducted and our results indicate that this batch of product was processed without incident related to this complaint and therefore there is no evidence of manufacturing anomalies on the paperwork reviewed. Further, a review into the depuy synthes mitek complaints system revealed no similar complaint of any kind for this lot of devices that were released to distribution. A white paper was performed previously on this failure; the result indicated that the amount of shedding for this product is acceptable. At this point in time, 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. Udi: (b)(4).
 
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Brand NameOMNICUT 5.2 (USED W/ MICRO HANDPIECE)
Type of DeviceMITEK FMS BLADES & BURRS
Manufacturer (Section D)
DEPUY MITEK
325 paramount drive
raynham MA 02767
Manufacturer Contact
jennifer lawrence
325 paramount drive
raynham, MA 02767
5089776860
MDR Report Key6382562
MDR Text Key69202619
Report Number1221934-2017-10096
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
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
Report Date 02/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2017
Device Catalogue Number283346
Device Lot NumberA1211001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/24/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location Hospital
Date Report to Manufacturer02/06/2017
Date Manufacturer Received04/24/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/19/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 03/06/2017 Patient Sequence Number: 1
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