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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 10.0MM REAMER HEAD FOR RIA 2 STERILE ARTHROSCOPE

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SYNTHES GMBH 10.0MM REAMER HEAD FOR RIA 2 STERILE ARTHROSCOPE Back to Search Results
Catalog Number 03.404.016S
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/10/2021
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 that the ria 2 was used to perform a bone graft on the right femur of the patient to use it on its left femur to compensate a large bone defect (2nd step of masquelet technique). Initially, the bone defect had been temporarily fixed with cement to enable an induced membrane. Preoperative planning was set to first use a 10 mm diameter reamer head and then a 14 mm diameter one based on the measured medullary canal at its narrower part. Another system with modified trinkle drill attachment was used. The entry point was done on the greater trochanter with the leg of the patient in good adduction so that the ria 2 drive shaft was fully and perfectly aligned with the medullary canal. A tissue protector was used to protect surrounding tissues from being damaged during the use of the ria 2. The surgeon was fully aware and cooperative with the technique doing gentle and smooth forwards and backwards movements with the reamer to prevent any failure of the system. Everything went perfectly well until the wings of the 10 mm ria 2 reamer head had broken and in the distal third of the femur. The debris was removed from inside of the intramedullary canal using different techniques (aspiration of the ria 2 and then a micro instrument used in orl and maxillo facial surgery to remove them). (3) out of (4) wings were successfully removed. One was left in place. There was a (60) minute delay but the procedure was completed. This report is for (1) 10. 0mm reamer head for ria 2 sterile. This is report 1 of 1 for (b)(4).
 
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Brand Name10.0MM REAMER HEAD FOR RIA 2 STERILE
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12020154
MDR Text Key259186690
Report Number8030965-2021-05050
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K111437
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Notification
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.404.016S
Device Lot Number62P2871
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/12/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/22/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown
Removal/Correction NumberZ-0571-2021

Patient Treatment Data
Date Received: 06/17/2021 Patient Sequence Number: 1
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