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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L85 TAN ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L85 TAN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.027.052S
Device Problems Failure to Advance (2524); Device-Device Incompatibility (2919)
Patient Problems Bone Fracture(s) (1870); No Code Available (3191)
Event Date 04/09/2019
Event Type  Injury  
Manufacturer Narrative
Due to the intra-operative events, the device was not successfully implanted. An alternate device was used to complete procedural step. As such, implant/explant dates are not applicable. 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 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. 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 (orif) with (b)(6) proximal femoral nail antirotation (pfna-ii) system to treat left femoral trochanteric fracture. An unknown nail with 130 degree was selected. However, at the middle of an insertion of the pfna-ii blade with 85mm into the patient's leg, the blade could not be advanced further. At that time, the sale consultant who was presented at the surgery became aware that an unknown aiming arm used for the blade insertion was for 125 degree. Thus, the surgeon removed the blade and changed an aiming arm to the correct one. Then, the surgeon connected the blade to an unknown impactor but were not connected properly. So, when the surgeon tried to lock the blade, it could not be locked, thus, the impactor detached from the blade. Moreover, the surgeon tried to re-connect them, however, it was not successful. Thus, the surgeon thought that the locking mechanism of the blade broke. Then, surgeon removed the blade and inserted another new blade with 80mm. The procedure was successfully completed with a sixty (60) minutes surgical delay. Patient is currently in the hospital. The sales rep commented that based on x-rays from the front view, the position of the blade was upper than the proper position. Besides, the blade insertion was done twice during the surgery and the bone was partially broken during an insertion of the first blade. Additionally, after completion of the second blade insertion, the bone was partially broken around the blade. There was a possibility of performing an artificial bone head replacement if pain continues. Surgeon then commented that there was a risk of cut out when bearing was started and dry checked of device combination should have been done. Concomitant device reported: unknown insertion handle (part# unknown, lot# unknown, quantity 1). This report is for one (1) pfna-ii blade 85mm. This is report 1 of 4 for complaint (b)(4).
 
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Brand NamePFNA-II BLADE L85 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 Key8590882
MDR Text Key144421742
Report Number8030965-2019-63628
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 04/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.027.052S
Device Lot Number2L10407
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 Received05/09/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/05/2018
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: 05/08/2019 Patient Sequence Number: 1
Treatment
UNK - NAIL INSERTION HANDLES
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