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

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

Patient Problems Hematoma (1884); Non-union Bone Fracture (2369); Joint Dislocation (2374); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown elastic nails (2.0 mm)/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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.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: eickhoff, a.Et al (2018), complications after intramedullary stabilization of clavicle fractures, unfallchirurg, vol.121, pages 810-816, ((b)(6)) the goal of this study was evaluation of predictors for medial nail migration and comparison with plate osteosynthesis for many years.Between january 1, 2010 and december 31, 2014, a total of 141 patients (22 females and 119 males) were enrolled, of which 99 were treated with intramedullary osteosynthesis and 42 with plate osteosynthesis.The implants used were elastic titanium nails of 2.0 mm/2.5 mm/3.0 mm thickness and 6- to 9-hole 3.5 mm lcp or anatomical clavicle plates (all products of depuysynthes gmbh, umkirch, (b)(6)).The following complications were reported as follows: patients who were treated with intramedullary osteosynthesis, 7 percent had severe complications, 17.2 percent had moderate complications, 15.2 percent had mild complications.15 patients required a second surgical procedure, 9 patients, the migrated ten was inserted somewhat further and/or shortened (moderate complication), 5 patients, conversion to plate osteosynthesis was necessary due to unacceptable misalignment, severe dislocation or pseudarthrosis, 1 patient had to have hematoma removal.1 patient had ten repeatedly deflected dorsally.2 patients who had pseudoarthrosis required prior open reduction.Medial wire migration of varying severity occurred in 26 cases.Medial migration of the titanium nail was associated with 66.7% of all mild complications, 81.3% of all moderate complications and 37.5% of all severe complications.Patients who were treated with plate osteosynthesis, 7.1 percent had severe complications, 7.1 percent had mild complications, 7.1 percent had moderate complications.1 patient had pseudoarthrosis.2 patients had implant rupture.3 patients needed further operations.3 patients had irritation in the area of the plate bearing.2 patients had complete metal removal was not possible.1 patient had a neurological limitation in the form of tingling paresthesia in the area of the dermatome c5 was observed postoperatively.This report is for an unknown synthes elastic titanium nails of 2.0 mm thickness.It captures the reported mild, moderate severe complications, conversion to plate osteosynthesis was necessary due to unacceptable misalignment, severe dislocation or pseudarthrosis, hematoma removal.A copy of the literature article is being submitted with this medwatch.This is report 1 of 10 for (b)(4).

• Brand Name: UNK - ELASTIC NAILS
• Type of Device: NAIL, FIXATION, BONE
• 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: 10809713
• MDR Text Key: 217438861
• Report Number: 8030965-2020-08761
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• 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: 10/12/2020
• 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