• 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 11MM/125 DEG TI CANN TFNA 170MM - 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 11MM/125 DEG TI CANN TFNA 170MM - STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.037.112S
Device Problem Device Difficult to Maintain (3134)
Patient Problems Pain (1994); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). Device evaluated by mfr, manufacture date: the investigation could not be completed; no conclusion could be drawn at the time of filing this report. A review of the device history record has been requested. Device was used for treatment, not diagnosis.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the patient presented to the hospital with hip pain due to fall post - operatively on (b)(6) 2019. Imaging confirmed a medial migration of the proximal lag screw in trochanteric femoral nailing advanced (tfna) nail through the femoral head and into the pelvic region. The patient had significant alcohol and mental health issues and may have been overdoing it regarding his mobilisation post the insertion of the tfna nail. So, there is a possibility that the screw had started to migrate into the pelvis prior to the fall that brought him to the hospital. The patient was originally implanted with tfna system on (b)(6) 2019. A tfna removal was required followed by a hip replacement in which the revision surgery took place on (b)(6) 2019. The procedure was completed successfully and all implants were explanted. The patient was an in-patient until day 15 and it is unclear as to whether the patient was compliant post discharge. There was no general surgical review that was conducted and that there was no intra-abdominal injuries as per surgeon's impression. Also, there was no abnormality discovered (nad) for blood with the patient's urine and stool. The surgeon believes that this occurred as a result of the screw not being locked off correctly at the primary insertion of the tfna nail. There was also no bone trauma and spicules of bone forced into the pelvis when they opened the patient¿s pelvis to remove the screw. The hole on the inner aspect of the pelvis was about 2. 5 cm in diameter with no bone spicules visible. Also, the surgeon checked the nail once it was removed from the femur and found that the ¿grub screw¿ / locking screw was not down at the region of the proximal hole where the lag screw would normally be locked off and therefore believes that it was never locked off sufficiently to begin with. It is unknown if there was a surgical delay. Patient and procedure outcome were unknown. Concomitant device/s reported: locking screw ( part# 04. 005. 528s, lot# 1l76220, quantity 1). This complaint involves two (2) devices. This report is for one (1) 11mm/125 deg ti cann tfna 170mm - sterile. This report is 2 of 2 for (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name11MM/125 DEG TI CANN TFNA 170MM - 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 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8720270
MDR Text Key148748407
Report Number8030965-2019-65543
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K160167
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 05/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.037.112S
Device Lot NumberH721428
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 Received08/20/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/29/2018
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: 06/20/2019 Patient Sequence Number: 1
-
-