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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° L360 TAN ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH PFNA Ø10 LONG R 130° L360 TAN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.027.226S
Device Problem Break (1069)
Patient Problems Unspecified Infection (1930); Impaired Healing (2378); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
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. 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 device history record review has been requested. (b)(4). 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 (b)(4) reports an event as follows: it was reported that on an unknown date, the patient was treated for subtrochanteric fracture with proximal femoral nail antirotation (pfna) nail. After twelve (12) months of no healing, the nail broke and still no union. The patient underwent revision to 95 degrees angled blade plate and bone graft on an unknown date. The surgery was completed by using a plier to remove the broken implants without finishing the step. Investigation for low-grade infection is still ongoing. There was no delay during the procedure. Reported patient outcome is routine, and patient is mobile. Concomitant device reported: pfna blade: (part: 04. 027. 034s, lot: l560129, quantity: 1), bolt ø4. 9 self-tap l44 (part: 459. 440, lot: 5942055, quantity: 1), bolt ø4. 9 self-tap l42 (part: 459. 420, lot: unknown, quantity: 1). This report is for a pfna nail. This is report 1 of 1 for (b)(4).
 
Event Description
Device report from (b)(6) reports an event as follows: it was reported that on an unknown date, the patient was treated for subtrocateric fracture with proximal femoral nail antirotaion (pfna) nail, after twelve (12) months of no healing, the nail broke and still no union. The patient underwent revision to 95 degrees andre blade plate and bone graft on (b)(6), 2018. The surgery was completed by using a plier to removed the broken implants without finishing the step. Investigation for low-grade infection was confirmed. There was no delay during the procedure. The patient outcome reported is routine. This is report 1 of 4 for (b)(4).
 
Manufacturer Narrative
Concomitant medical products: initially reported concomitant devices became reportable devices. 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.
 
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Brand NamePFNA Ø10 LONG R 130° L360 TAN
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
MDR Report Key8121415
MDR Text Key129024681
Report Number8030965-2018-58665
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,Followup
Report Date 11/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.027.226S
Device Lot NumberL282235
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/16/2019
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 11/30/2018 Patient Sequence Number: 1
Treatment
SEE EVENT DESCRIPTION
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