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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - ELASTIC NAILS ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - ELASTIC NAILS ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Irritation (2076)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown synthes titanium elastic nail (ten)/unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. Product was not returned. 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
This report is being filed after the review of the following journal article: khuntia s. , swaroop s. , patro b. , sahu s. , (2020)paediatric long bone fractures managed with elastic intramedullary nails: a retrospective study of 30 patients, cureus , volume 12(4), pages 1-10 (india). This retrospective study aims to discuss the use of a titanium elastic nail (ten) in the management of all long bone fractures in children more than the age of six years and less than 15 years and share our experience to add to the evidence in the management of long bone fractures in the paediatric age group. From january 2014 - february 2016, a total of 21 male and nine female patients ,mean age at the time of surgery was 10 years (six to 15 years), with long bone fractures operated with an elastic intramedullary nail were included in the study. Two nails with the same diameter were selected to balance the opposing bending forces and avoid mal-alignment the mean follow-up period was 26 months (18 - 44 months). The following complications were reported as follows: in most cases, the fracture was manipulated by closed methods and the nail introduced across the fracture site but in six cases, we faced difficulty and an incision was made to reduce the fracture site directly for passage of the nail. In two femur fractures, the entry point was a bit anterior and caused the nail to protrude into the knee joint, causing pain and effusion. They resolved successfully on the removal of the nail. Limb length discrepancy of more than 1 cm, i. E. , the operated limb longer than the normal limb was seen in three femur fractures, but it was not functionally significant. A case of an 8 year old male had pain and superficial wound infection (femur). A case of a 14 year old female had pain and superficial wound infection (tibia). A case of a 13 year old male had pain and superficial wound infection (tibia). A case of a 9 year old male had nail end/hardware prominence (femur). A case of an 11 year old male had nail end/hardware prominence (femur). A case of a 9 year old male had nail end/hardware prominence (femur). A case of an 8 year old female had pain and nail end/hardware prominence (forearm). A case of a 7 year old male had pain. A case of a 13 year old male had a rotational malalignment (degree) of 5 to 10. A case of a 10 year old female had a rotational malalignment (degree) of 5 to 10. A case of an 8 year old male had pain postoperatively with < 1 cm (1. 2). (one of the three femur fractures with limb length discrepancy of more than 1 cm) a case of a 10 year old male had limb length discrepancy < 2 cm (1. 2). (one of the three femur fractures with limb length discrepancy of more than 1 cm) this is report 6 of 8 for (b)(4) (9 year old male). This complaint is linked to (b)(4). This report is for an unknown synthes titanium elastic nail (ten). A copy of the literature article is being submitted with this medwatch.
 
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Brand NameUNK - ELASTIC NAILS
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10762776
MDR Text Key214100872
Report Number8030965-2020-08411
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received10/05/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/30/2020 Patient Sequence Number: 1
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