• 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 9MM/125 DEG TI CANN TFNA 320MM/LEFT - STERILE 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 9MM/125 DEG TI CANN TFNA 320MM/LEFT - STERILE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.037.923S
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. (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 the patient as implanted with trochanteric fixation nail-advanced (tfna) system on (b)(6) 2020. On (b)(6) 2020 the surgeon informed of cut-through. After confirmation of cut-through, the patient was weaned. On (b)(6) 2020, reoperation was performed to remove the tfna and fix the bone again by using another nail system. Per surgeon the reason of the cut-through is what there are poor repositioning, the placement position of the blade was toward the front and didn¿t allow the blade sliding. No further information is available. Concomitant devices: titanium locking screw (part# 04. 005. 522s, lot# 2l52816, quantity 1). Titanium locking screw (part# 04. 005. 524s, lot# 27p1280, quantity 1). Proximal femoral nailing system (tfna) end cap (part# 04. 038. 000s, lot# 5l91318, quantity 1). Tfna nail (part# 04. 037. 923s, lot# 13l0148, quantity 1). This report is for one (1) 9mm/125 deg ti cann tfna 320mm/left - sterile. This is report 2 of 2 for complaint (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name9MM/125 DEG TI CANN TFNA 320MM/LEFT - STERILE
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key10393541
MDR Text Key202537857
Report Number8030965-2020-05872
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K131548
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 07/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.037.923S
Device Lot Number13L0148
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2019
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: 08/11/2020 Patient Sequence Number: 1
-
-