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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

510k: 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.(b)(4).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.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 (b)(6) male had pain and superficial wound infection (femur) a case of a (b)(6) female had pain and superficial wound infection (tibia) a case of a (b)(6) male had pain and superficial wound infection (tibia) a case of a (b)(6) male had nail end/hardware prominence (femur) a case of an (b)(6) male had nail end/hardware prominence (femur) a case of a (b)(6) male had nail end/hardware prominence (femur) a case of an (b)(6) female had pain and nail end/hardware prominence (forearm) a case of a (b)(6) male had pain.A case of a (b)(6) male had a rotational malalignment(degree) of 5 to 10.A case of a (b)(6) female had a rotational malalignment(degree) of 5 to 10.A case of an (b)(6) 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 (b)(6) 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 4 of 10 for (b)(4).((b)(6) male) this complaint is linked to (b)(4).This report is for an unknown synthes titanium elastic nail (ten).

• Brand Name: UNK - ELASTIC NAILS
• Type of Device: ROD, 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 Key: 10763783
• MDR Text Key: 217084767
• Report Number: 8030965-2020-08437
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• 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 Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR