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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 13.0MM REAMER HEAD FOR RIA 2 STERILE ACCESSORIES, ARTHROSCOPIC

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OBERDORF SYNTHES PRODUKTIONS GMBH 13.0MM REAMER HEAD FOR RIA 2 STERILE ACCESSORIES, ARTHROSCOPIC Back to Search Results
Catalog Number 03.404.022S
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problems Foreign Body In Patient (2687); No Code Available (3191)
Event Date 07/22/2020
Event Type  Injury  
Manufacturer Narrative
Additional product code hto. (b)(4). The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. 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 synthes reports an event in (b)(6) as follows: it was reported on an unknown date that during an unknown surgery the wings of the ria2 drill bit was break. The surgeon used drill head to complete the procedure. There was fragment generated and the wings of drill head remains in the patient body. The surgery was completed successfully with 10 minutes delay. There were no consequences of the patient. This complaint involves one (1) device. This report is for (1) 13. 0mm reamer head for ria 2 sterile. This is report 1 of 1 for (b)(4).
 
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Brand Name13.0MM REAMER HEAD FOR RIA 2 STERILE
Type of DeviceACCESSORIES, ARTHROSCOPIC
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10346264
MDR Text Key201325011
Report Number8030965-2020-05500
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K993335
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,Followup
Report Date 07/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.404.022S
Device Lot Number46P3569
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/30/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/27/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/30/2020 Patient Sequence Number: 1
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