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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 Problems Device-Device Incompatibility (2919); Device Difficult to Maintain (3134)
Patient Problem No Code Available (3191)
Event Date 11/01/2018
Event Type  Injury  
Manufacturer Narrative
Device is not distributed in the united states, but is similar to device marketed in the usa. (b)(4). It was reported that the guide sleeve could not be disassembled from the aiming arm. The surgery was completed using a different aiming arm of a different angle the investigation could not be completed; no conclusion could be drawn at the time of filing this report. 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.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, a gamma nail open reduction internal fixation (orif) for proximal femoral fracture was performed with proximal femoral nailing system (tfna). During the procedure, the guide sleeve and the aiming arm became unable to be detached. The surgery was completed by using another aiming arm of a different angle and fixed the distal area with the devices. After the surgery, the sales representative confirmed that the sleeve and the arm could be detached. There was no surgical delay and no adverse consequence to the patient. This report is for one (1) aim-arm 125° f/stat+dyn dist lock. This complaint involves two (2) devices. This report is 1 of 2 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)
WERK HÄGENDORF (CH)
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 
6107195000
MDR Report Key8087204
MDR Text Key127853939
Report Number8030965-2018-58364
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
Type of Report Initial,Followup,Followup
Report Date 11/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.037.114
Device Lot Number9663745
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/18/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/19/2018 Patient Sequence Number: 1
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