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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH REAMER Ø11 F/PFNA BLADE

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OBERDORF SYNTHES PRODUKTIONS GMBH REAMER Ø11 F/PFNA BLADE Back to Search Results
Catalog Number 356.821
Device Problems Break; Material Fragmentation
Event Date 10/21/2018
Event Type  Injury  
Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Device is not distributed in the united states, but is similar to device marketed in the usa. (b)(4). A review of the device history records has been requested. Device was used for treatment, not diagnosis.

 
Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that a proximal femoral nail antirotaion (pfna) was used on an orthopedic procedure on (b)(6) 2018. During insertion of the right nail and guide wire, the lateral cortex was drilled and tried to ream the femur head but the reamer broke. The implant was changed into a2fn recon and tried to find the optimum position for recon hip screw, while drilling for recon hip screw, the drill bit was broken. The implant was changed again to a standard locking a2fn. It is unknown how the surgery was completed. The procedure was delayed four hours and required prolonged anesthesia on the patient. This complaint is for one (1) reamer concomitant device reported: unknown drill guide: (part# unknown, lot# unknown, quantity# 1), unknown nail (part# unknown, lot# unknown, quantity# 1), unknown guide wire (part# unknown, lot# unknown, quantity# 1). This complaint involves three (3) devices this report is 3 of 3 for (b)(4).

 
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Brand NameREAMER Ø11 F/PFNA BLADE
Type of DeviceREAMER
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
michael cote
1302 wrights lane east
west chester  19380
6107195000
MDR Report Key8048521
Report Number8030965-2018-58023
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 10/21/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/07/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number356.821
Device LOT NumberU200200
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/20/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/24/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/24/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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