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

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

Patient Problems Bone Fracture(s) (1870); Scar Tissue (2060); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown elastic nail/ 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.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: jubel a., andermahr j., schiffer g., schiffer k.E., (2002) the technique of intramedullary nailing of clavicular fracture with the titanium elastic nail (ten), trauma surgeon volume 105, pages 511¿516, (germany).This study aims to assese the outcome of teh technique of intramedullary nailing of clavicular fracture with the titanium elastic nail (ten).From december 1996 to april 2000, a total of 62 patients (46 males, 16 females) with mean age of 33.4 ± 13.6 years (range 13-74 years, median age 32) with 65 fractures of the clavicle underwent intramedullary osteosynthesis.The ten-set (synthes ltd., bochum) standard instrument, in addition 2 small angled awl to expand the proximal medullary cavity were used.In most cases, a 3-mm-nail was used.In delicate patient a nail with a diameter of 2.5 mm.Thinner (2 mm) or greater (3.5 mm) implants were required only in 2 cases.Metal removal was recommended in patients with radiologically proven fracture healing.The patients were examined clinically for 3.7, 21 and 42 days.The following complications were reported as follows: in 4 patients, shortening of the long nail at the point of impact which led to pain and skin irritation was carried out after a period of 1-33 weeks after thefirst operation.In a patient with a multi-fragmental fracture, we saw a secondary shortening of the clavicle by 1.5 cm radiologically.A pseudoarthrosis occurred in one polytraumatised patient.There was hypertrophic kscar in 2 cases.1 non-union.Fig.6 : intraoperative findings: open reduction of a fracture with a blown off fragment.Accidental eruption of the clavicle.This report is for an unknown synthes titanium elastic nail (ten).This report captures the reported events of a patient with a multi-fragmental fracture, a secondary shortening of the clavicle by 1.5 cm radiologically, a pseudoarthrosis occurred in one polytraumatised patient, hypertrophic scar in 2 cases, non-union and open reduction of a fracture with a blown off fragment, accidental eruption of the clavicle.This is report 2 of 2 for (b)(4).

• Brand Name: UNK - ELASTIC NAILS
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10987264
• MDR Text Key: 220912793
• Report Number: 8030965-2020-09587
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• 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: 11/16/2020
• 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