• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OBERDORF SYNTHES PRODUKTIONS GMBH PFNA BLADE PERF L105 TAN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.027.036S
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/10/2018
Event Type  malfunction  
Manufacturer Narrative
Device malfunctioned intra-operatively and was not implanted / explanted. Device is not distributed in the united states, but is similar to device marketed in the usa. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. A device history records review 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 in (b)(6) as follows: it was reported that the proximal femoral nail antirotation (pfna) blade was used for an unknown surgery on (b)(6) 2018. When the surgeon locked the blade, the impactor was unlocked from the blade, but the surgeon could see on x-ray that the blade has not been closed in the gap as it should have. The surgeon removed the blade, and replaced it with a new pfna blade. There was no problem unpacking the original blade, mounting it on to the inserter, or impacting it in the femoral head. Surgery was successfully completed. There were no reported patient consequences. Concomitant devices: pfna nail (part: unknown, lot: unknown: quantity: 1) impactor (part: unknown, lot: unknown: quantity: 1) this report is for a pfna blade perf l105 tan. This is report 1 of 1 for (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7660206
MDR Text Key113192529
Report Number8030965-2018-54799
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeDA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.027.036S
Device Lot NumberL893128
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/22/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

-
-