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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI END CAP FOR TFNA 0MM EXTN ¿ STERILE ROD,FIXATION,INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH TI END CAP FOR TFNA 0MM EXTN ¿ STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.038.000S
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/16/2018
Event Type  malfunction  
Manufacturer Narrative
Additional narrative: device remained implanted. Device is not expected to be returned for manufacturer review/investigation. Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. 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 orif (open reduction internal fixation) was applied to femoral trochanteric fractures on (b)(6) 2018. During the surgery, the surgeon could not tighten the end cap (0mm in size). He used another end cap (5mm in size) and he could tighten it. However, he was concerned about adverse event (pain, etc) due to bigger size, so he put the end cap (0mm in size) back in place. The end cap did not fit to a nail properly. The surgery was completed within 30-minutes delay. There was no adverse consequence to the patient. Surgery was completed successfully with patient in stable condition. Concomitant device reported: nail (part# unknown, lot# unknown, quantity 1). This report is for one (1) ti end cap for tfna 0mm extn ¿ sterile. (b)(4).
 
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Brand NameTI END CAP FOR TFNA 0MM EXTN ¿ STERILE
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ 2544
Manufacturer Contact
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7595604
MDR Text Key110862440
Report Number8030965-2018-54300
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K160167
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 05/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.038.000S
Device Lot NumberL716787
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 Received07/25/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/16/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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