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 Injury (2348)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown nail/unknown lot.Part and lot numbers are unknown; udi number is unknown.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: park, k.B.Et al.(2018), cortical erosion after elastic stable intramedullary nail fixation for pediatric long bone fractures: case series according to the site, international journal of surgery, vol.55, pages 60-65 ((b)(6)).The aim of this study was to investigate the prevalence of cortical erosion by esin, in relation to the site and the clinical consideration of the radiological findings.Between june 1996 to november 2016, a total of 221 patients (223 fractures; 165 males and 56 females) with mean age of the patients was 10 years and 2 months (range, 3¿16 years) were treated with 2 symmetrically bent nails were used in combination with the 3-point fixation principle.Implants used were titanium elastic nails were used for all the patients (synthes, west chester, pennsylvania).The following complications were reported as follows: cases with cortical disruption at diaphysis.Patient 1: a (b)(6)-year-old male patient had a cortical disruption at diaphysis in the forearm.Patient 2: a (b)(6)-year-old male patient had a cortical disruption at diaphysis in the forearm.Patient 3: a (b)(6)-year-old male patient had a cortical disruption at diaphysis in the forearm.Patient 4: a (b)(6)-year-old male patient had a cortical disruption at diaphysis in the forearm.Patient 5: a (b)(6)-year-old female patient had a cortical disruption at diaphysis in the forearm.Patient 6: a (b)(6)-year-old male patient had a cortical disruption at diaphysis in the forearm.Patient 7: a (b)(6)-year-old male patient had a cortical disruption at diaphysis in the forearm.Patient 8: a (b)(6)-year-old male patient had a cortical disruption at diaphysis in the forearm.Patient 9: an (b)(6)-year-old male patient visited our emergency room with both forearm bone fractures caused by a fall from a monkey bar.After fixation with two flexible intramedullary nails, the fracture was well aligned.At the 14-month follow-up, cortical erosion at the proximal radius was noted, and the nail was protruded into the distal ulna patient 10: a (b)(6)-year-old male patient had a cortical disruption at diaphysis in the forearm.Patient 11: a (b)(6)-year-old male patient had a cortical disruption at diaphysis in the forearm.Patient 12: a (b)(6)-year-old male patient had a cortical disruption at diaphysis in the forearm.Patient 13: a (b)(6)-year-old male patient visited our emergency room after being hit by a car.The patient visited the outpatient clinic at 41 months after the index surgery.Anteroposterior radiograph shows cortical erosion by the titanium elastic nail at the mid-shaft of the tibia.Ct image shows the titanium elastic nail to be enclosed by the cortex.Patient 14: a (b)(6)-year-old male patient had a cortical disruption at diaphysis in the tibia.Patient 15: a (b)(6)-year-old male patient had a cortical disruption at diaphysis in the tibia.The patient visited an outpatient clinic at 4 years and 8 months after the index surgery.The initial radiographs showed fractures of both tibia and fibula.The fracture was fixed with two flexible intramedullary nails.Anteroposterior radiograph shows invasion of the titanium elastic nails into the cortex.Ct images show that the nails were buried in the cortical bone.Cases with cortical disruption at metaphysis-diaphysis junction.Patient 1: a (b)(6)-year-old male patient had cortical disruption at metaphysis-diaphysis junction in the humerus.Patient 2: a (b)(6)-year-old female patient had cortical disruption at metaphysis-diaphysis junction in the humerus.Patient 3: a (b)(6)-year-old male patient had cortical disruption at metaphysis-diaphysis junction in the humerus.Patient 4: a (b)(6)-year-old male patient had cortical disruption at metaphysis-diaphysis junction in the forearm.Patient 5: a (b)(6)-year-old female patient had cortical disruption at metaphysis-diaphysis junction in the forearm.Patient 6: an (b)(6)-year-old male patient had cortical disruption at metaphysis-diaphysis junction in the forearm.Patient 7: an (b)(6)-year-old male patient had cortical disruption at metaphysis-diaphysis junction in the forearm.Patient 8: a (b)(6)-year-old male patient had cortical disruption at metaphysis-diaphysis junction in the tibia.Patient 9: a transverse fracture of the tibia in a (b)(6)-year-old female patient was fixed with two 2.5-mm titanium elastic nails.At 8 months' post-surgery, the tip of the nail had protruded after migrating from the relatively wide metaphysis of the tibia to its relatively narrow diaphysis, as seen on oblique radiographs.Considering residual growing, continuous migration of nail has a high possibility as a stress riser by moving to diaphysis.Patient 10: an (b)(6)-year-old male patient had cortical disruption at metaphysis-diaphysis junction in the tibia.All patients underwent hardware removal surgery and there were no problems, such as iatrogenic fracture or difficulty during removal.The average time for hardware removal in patients with cortical erosion was 14.2 months.This report is for an unknown synthes esin this is report 1 of 10 for (b)(4) the complaint involves 50 devices.Due to a limit of impacted products per complaint, this complaint will be captured under 5 separate complaints as listed below: (b)(4)¿ this complaint will include 10 devices - 10 esin (1st pc).(b)(4)- this complaint will include 10 devices - 10 esin (2nd pc).(b)(4)- this complaint will include 10 devices - 10 esin (3rd pc).(b)(4)- this complaint will include 10 devices - 10 esin (4th pc).(b)(4)- this complaint will include 10 devices - 10 esin (5th pc).For the overall complaint, adverse event review activity, mdv activity, and additional information request activity will be documented in (b)(4).A copy of the literature article is being submitted with this medwatch.

• 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: 10792596
• MDR Text Key: 217322592
• Report Number: 8030965-2020-08622
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• 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: 10/09/2020
• 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: 10 YR