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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH AIM-ARM 125 F/STAT+DYN DIST LOCK ROD,FIXATION,INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH AIM-ARM 125 F/STAT+DYN DIST LOCK ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 03.037.114
Device Problem Device-Device Incompatibility (2919)
Patient Problem Tissue Damage (2104)
Event Date 01/24/2020
Event Type  Injury  
Manufacturer Narrative
Device is not distributed in the united states, but is similar to device marketed in the usa. Without a lot number the device history records review could not be completed. Product was not returned. 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 that on (b)(6) 2020, the patient underwent a surgery for the femoral trochanteric fracture with the aiming arms (03. 037. 114, 03. 037. 113) and the flexible screwdriver in question. During the surgery, the surgeon felt difficulty using the aiming arms because they were too heavy. And he thought that only the part of the flexible driver around 20 mm from the tip needed to be bent. He could not connect the driver to other devices without making more incision of 10cm and adducting the affected leg because the whole screwdriver bent. The surgery completed within a thirty (30) minute surgical delay. No further information is available. This is report 1 of 3 for (b)(4).
 
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Brand NameAIM-ARM 125 F/STAT+DYN DIST LOCK
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
SYNTHES SELZACH
bohackerweg 5
selzach 2545
SZ 2545
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key9720382
MDR Text Key191676282
Report Number8030965-2020-01193
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.037.114
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/24/2020
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?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/18/2020 Patient Sequence Number: 1
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