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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA Ø10 LONG R 130° L380 SST ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH PFNA Ø10 LONG R 130° L380 SST ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 272.295S
Device Problem Break (1069)
Patient Problem Failure of Implant (1924)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative
It is unknown if the 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. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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. A review of the device history records has been requested. 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 (b)(4) reports an event as follows: it was reported that on (b)(6), 2018, a proximal femoral nail anti-rotation (pfna) nail broke on a walk. Initially, the pfna nail was implanted on (b)(6) 2018. The patient underwent a revision on (b)(6) 2018. It is unknown how the procedure was completed. Patient outcome is unknown. Concomitant devices: locking screw (part/lot unknown, quantity 1); pfna blade (part/lot unknown, quantity 1). This report is for a pfna nail. This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
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
After the revision surgery, the patient was weakened with more pain than they experienced after the first operation. The recuperation also took longer.
 
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Brand NamePFNA Ø10 LONG R 130° L380 SST
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
MDR Report Key8126303
MDR Text Key129148371
Report Number8030965-2018-58711
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
Type of Report Initial,Followup,Followup
Report Date 11/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/01/2017
Device Catalogue Number272.295S
Device Lot NumberL546915
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/05/2019
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 12/03/2018 Patient Sequence Number: 1
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