MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; ROD,FIXATION,INTRAMEDULLARY

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

Patient Problems Pain (1994); Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

This report is for unknown quantity of unknown titanium elastic nails.Part#, lot# and udi # is not available.Device is not expected to be returned for manufacturer review/investigation.This report is for unknown quantity of unknown titanium elastic nails.Pma/510(k) number is not available.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: muller mc, burger c et al (2007).Elastic titanium nail for the minimally invasive osteosynthesis of the clavicle shaft fracture.Der chirurg; zeitschrift fur alle gebiete der operativen medizen.Volume 78.Pages 349-355 (germany).This retrospective study aims to analyze the results and complications of the use of elastic titanium nail (ten) for the minimally invasive osteosynthesis of the clavicle shaft fracture.Between september 2000 until august 2005, 45 patients with middle third clavicle fracture who underwent intramedullary osteosynthesis with an elastic titanium nail (ten) were included in the study.There were 33 men and 13 women with an average age of 44.1 years.All patients were implanted with an unknown synthes 2.5mm or 3.5mm titanium elastic nail (ten).Only 33 patients were available for follow-up.Postoperatively, shoulder joint function was assessed using the constant and murley scores (0 to 100 points, maximum of 100).The function of the arm in daily life was evaluated as per the dash score (disability of the arm, shoulder and hand, 0 to 100 points, optimum value is 0).Median follow-up time is 24.7+/- 2.4 months.Average implant removal of 5.9 months (range, 1.5 to 15 months).Complications were reported as follows: two patients had implant breakage during follow-up which occurred after the fracture was healed.The lateral portion of the ten were left in place since patients were free of complications.Two patients had perforation of the laterodorsal cortex during the initial intervention upon using the hammer.One patient had the 2.5mm ten replaced with a 3.5mm ten and eventually the fracture healed without any problems.One female patient who had perforation of the laterodorsal cortex during the initial intervention upon using the hammer has the 2.5mm ten left in place.Consequently, a lateral migration occurred which required 2 retroactive shortenings.The patient achieved a functionally unsatisfactory result (constant and murley score of 48 points; dash score of 66 points).One patient had superficial wound infection that was treated.The ten was not removed.Eight patients had medial migration of the ten with pain and skin irritation in the area of the entry point of the nail.Five of these patients required secondary shortening of the nail with surgery done under local anesthesia.Twelve patients had sustained clavicular shortening of = 5 mm in relation to the intact contralateral side.In 6 patients, a shortening of the shoulder by 5mm to 30mm were measured as compared to the opposite side.One type b fracture healed with a shortening of 5mm.1 type c fracture healed with a shortening of 30 mm with the patient having cosmetic complaints but without functional effect.One patient had a case of brachial plexus injury.At 6 days post-op, patient presented significant pain, paresthesia, and functional impairment of the affected extremity.A lesion of the ulnar nerve was diagnosed.Radiographs showed that the lateral end of the ten had not engaged in the clavicle, but was situated in the brachial plexus.The nail was removed and the fracture healed without implant.Mean constant and murley score of 94.3+/-2 at 6 months post-op.Mean dash score of 5.4+/- 2.2 at 6 months post-op.This report is for unknown quantity of unknown titanium elastic nails.This is report 3 of 3 for (b)(4).

• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7929595
• MDR Text Key: 122484913
• Report Number: 8030965-2018-56941
• Device Sequence Number: 1
• Product Code: HSB
• 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: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• 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: 09/10/2018
• 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