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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II Ø10 XS 125° L170 TAN ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II Ø10 XS 125° L170 TAN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 472.101S
Device Problem Device Handling Problem (3265)
Patient Problem No Code Available (3191)
Event Date 12/03/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint #: (b)(4). Complainant part is not expected to be returned for manufacturer review/investigation. Device is not distributed in the united states, but is similar to device marketed in the usa. (b)(4). The patient will be under no weight bearing). Investigation summary product was not returned. Based on the information available, it has been determined that no corrective and 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 record. Device history lot: part: 472. 101s. Lot: 5l16200. Manufacturing site: (b)(4). Release to warehouse date: 11. July 2019. Expiry date: 01. July 2029. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified. 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 on (b)(6) 2019, the patient underwent an open reduction internal fixation surgery for the femoral trochanteric fracture with the pfna in question. Before the surgery, there was no problem with the devices when the hospital checked them. During the surgery when the surgeon was inserting the blade, he felt a resistance. He tried to remove it, but the blade could not be removed at all. The surgeon used an extraction screw and a hammer, but the blade could not be extracted. The surgeon used headless compression screw 4. 5/6. 5 for additional fixation. The patient will be under no weight bearing. The hospital plans a reoperation to remove or to cut the blade. No further information is available. Concomitant devices reported: unknown impaction instruments: hammer/mallet: trauma (part#: unknown, lot#: unknown, quantity#: 1) unknown extraction instruments: tfna/pfna (part#: unknown, lot#: unknown, quantity#: 1). This complaint involves two (2) devices. This report is for one (1) pfna-ii ø10 xs 125° l170 tan. This report is 1 of 2 for (b)(4).
 
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Brand NamePFNA-II Ø10 XS 125° L170 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
eimattstrasse 3
oberdorf 4436
SZ   4436
6103142063
MDR Report Key9507695
MDR Text Key188241220
Report Number8030965-2019-71343
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
Report Date 12/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number472.101S
Device Lot Number5L16200
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 Received12/03/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/11/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/20/2019 Patient Sequence Number: 1
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