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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US UNK - BLADES/BURRS;  ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

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DEPUY MITEK LLC US UNK - BLADES/BURRS;  ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE Back to Search Results
Catalog Number UNK - BLADES/BURRS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Concomitant medical products: unknown electrode, unknown implant.Without a lot number the device history records review could not be completed.Product was not returned.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.If additional information is made available, the investigation will be updated as applicable.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 Description
This is report 3 of 3 for the same event.This report is being filed after the review of the following journal article: cunningham, g., et al.(2015) "comparison of arthroscopic and open latarjet with a learning curve analysis", knee surgery sports traumatology arthroscopy, vol.24, pages 540-545, (switzerland).The study emphasizes on comparing arthroscopic and open latarjet performed by a single shoulder surgeon with learning curve analysis.The patients evaluated on course of this study: a retrospective review of a prospectively collected patient database was conducted, including 2 series of consecutive patients who underwent arthroscopic or open latarjet by a single shoulder surgeon (a.L.) between 2008 and 2014.All patients had significant bone loss with indication for a latarjet procedure according to established criteria [1, 5].Clinical stability, range of motion and walch-duplay scores were assessed preoperatively and on final follow-up.Operative times were systematically recorded al the lime of surgery by noting the beginning and end of each intervention.Intra- or postoperative complications, such as graft fracture, hematoma, infection, and neurological lesions, were also recorded.All patients had at least a true anteroposterior and an axillary or bemageau x-ray view [2, 2 l], postoperatively and at the latest follow-up.Sixty-four patients were included in die study, 28 in the arthroscopic group and 36 in die open group with similar age, sex ratio, and preoperative isis score.Operative time was significantly higher in the arthroscopic group (146 versus 81 min, p = 0.001), and although no intra-operative complications were recorded in either group, there were significantly more postoperative complications in the arthroscopic group (29 vs.11 %, p ¿ 0.03).Screw placement was more accurate in the open group, and postoperative walch-duplay score did not show any significant difference between the groups (88 points in the arthroscopic group and 91 points in the open group).The arthroscopic latarjet leaming curve analysis showed that the need for conversion ceased after the first 10 patients and that surgical time came close to that of open procedure after 20 procedures.The article describes the following procedure: arthroscopic and open latarjet procedures.The devices involved were: vapr, depuy mitek®, inc., raynham, ma, omnicut®, depuy mitek, inc., raynharti, ma, latarjet disposable kit®,-depuy mitek, inc., raynham, ma.Complications mentioned in the article were: there were 8 postoperative complications (29 %) in the arthroscopic group and 4 (11 %) in the open group (or = 4.4 95 % ci 1.1-18.5, p = 0.03).Arthroscopic: 2 non-union, 1 infection, and 1 haematoma, open: 2 infection, and 2 haematoma.
 
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Brand Name
UNK - BLADES/BURRS
Type of Device
 ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
5089776860
MDR Report Key9139831
MDR Text Key167387056
Report Number1221934-2019-58711
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK - BLADES/BURRS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/27/2019
Initial Date FDA Received10/01/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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