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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH DHS BLADE Ø12.5 L85 TAN ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH DHS BLADE Ø12.5 L85 TAN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.224.085S
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Code Available (3191)
Event Date 04/17/2018
Event Type  Injury  
Manufacturer Narrative
Patient information is unknown due to intra-operative issues, the device as not implanted/explanted. Device is not distributed in the united states, but is similar to device marketed in the usa. (b)(4). The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. 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 europe reports an event in (b)(6) as follows: it was reported that during an open reduction internal fixation (orif) procedure on (b)(6) 2018 there was an issue with the dynamic hip system (dhs) blade. When the 85mm dhs blade was prepared, it was found that the tip of the blade was immobile. Even when the locking mechanism was released, the tip was still immobile; the shaft part and the blade part did not rotate each other. A 90mm dhs blade was inserted instead. During that insertion, the surgeon hammered the blade and the tip of the inserter broke off. The fragment was removed, and the surgery was completed within a thirty (30) minute delay. The dhs plate was fully seated after the 90mm blade was implanted. There was no adverse consequence to the patient. Patient outcome is stable. Procedure was successfully completed. This is report 1 of 2 for (b)(4).
 
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Brand NameDHS BLADE Ø12.5 L85 TAN
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK GRENCHEN (CH)
solothurnstrasse 186
grenchen 2540
SZ 2540
Manufacturer Contact
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7494289
MDR Text Key107591039
Report Number8030965-2018-53613
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
Report Date 04/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.224.085S
Device Lot NumberL428317
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/30/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/22/2017
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: 05/08/2018 Patient Sequence Number: 1
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