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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA BLADE PERF L105 TAN ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH PFNA BLADE PERF L105 TAN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.027.036S
Device Problem Device Difficult to Maintain (3134)
Patient Problem No Patient Involvement (2645)
Event Date 01/01/2019
Event Type  malfunction  
Manufacturer Narrative
Expiration date and lot number unknown. 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. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed; no conclusion could be drawn at the time of filing this report. 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 during an unknown procedure on an unknown date, the proximal femoral nail antirotation (pfna) blade was unable to unlock with an unknown attached instrument. Thus, the procedure was successfully completed by using a new implant. There was a five (5) minutes of surgical delay reported. There was no patient consequence. Concomitant device reported: unknown pfna nail (part # unknown, lot # unknown, quantity 1). This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
 
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Brand NamePFNA BLADE PERF L105 TAN
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
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8759184
MDR Text Key149986151
Report Number8030965-2019-65987
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
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 06/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.027.036S
Device Lot Number3L31467
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/03/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/31/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/06/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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