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

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.

• 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 Key: 9139831
• MDR Text Key: 167387056
• Report Number: 1221934-2019-58711
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• 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 Number: UNK - 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 Received: 10/01/2019
• 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 Number: 1
• Patient Outcome(s): Required Intervention