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

MAUDE Adverse Event Report: SYNTHES GMBH PFNA-II 9 XS 130 L170 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
 

SYNTHES GMBH PFNA-II 9 XS 130 L170 TAN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 472.104S
Device Problems Material Deformation (2976); Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); Non-union Bone Fracture (2369)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative
Event year is reported as 2020; however exact date of event is unknown. Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. (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)(6) reports an event as follows: it was reported that on (b)(6) 2020 the patient underwent for a removal surgery due to broken nails. The surgeon confirmed that the nail had been broken and removed the nail with other implants due to non-union and implanted frn (femoral recon nail system) implants and artificial bone. It was unknown if the removal surgery completed successfully. The patient condition was stable. Concomitant devices reported: unknown nail head elements: pfna blade (part# unknown, lot# unknown, quantity 1). Unknown screws: locking: trauma (part# unknown, lot# unknown, quantity unknown). Unknown end caps: pfna (part# unknown, lot# unknown, quantity 1). This complaint involves two (2) devices. This report is for (1) pfna-ii ø9 xs 130° l170 tan. This report is 1 of 1 for (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePFNA-II 9 XS 130 L170 TAN
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES 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 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11166409
MDR Text Key228851372
Report Number8030965-2021-00284
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,Followup
Report Date 12/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number472.104S
Device Lot NumberL998547
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/09/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/08/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/13/2021 Patient Sequence Number: 1
-
-