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); Discomfort (2330)

Event Date 03/11/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).Device is not distributed in the united states, but is similar to device marketed in the usa.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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: hartmann f, hessmann mh, gercek e, rommens pm (2008).Elastic intramedullary nailing of midclavicular fractures.Acta chirurgica belgica.Volume 2008.Pages 428-432.((b)(6)).The aim of the present study was the evaluation of the operative technique and the functional and re-integrative results after esin of displaced midclavicular fracture.Between 2003 and 2006, a total of 15 patients, with midclavicular fractures who underwent elastic stable intramedullary nailing (esin), were included in the study.There were 12 males and 3 females with an average of 36.7 years (range, 15 to 65 years).Patients underwent fracture reduction and were implanted with an unknown synthes titanium elastic nail.Early physical therapy with a limitation of abduction of 90° is commenced for the first 3 to 4 weeks.Fracture healing, clinical outcome (visual analogue scale (vas) and clinical shoulder function per constant-murley score), and complications were assessed.Mean follow-up time was one year.Complications were reported as follows: a (b)(6) patient had complete acromioclavicular joint dislocation after reduction and elastic stable intramedullary nailing.Patient was revised with reconstruction of the acromioclavicular joint.Fracture healed after removal of titanium elastic nails (tens) at 16 weeks post injury.4 patients had suffered from skin irritation and pain at the sternal end of the clavicle at 1 to 4 months post-op.The prominent medial end of the titanium elastic nail (ten) had to be shortened in 3 patients while it has to be removed early at 5 months post-op in 1 patient.1 patient had a low activity level with constant-murley-score of 2 points.1 year post-injury, patient had excellent function of the affected shoulder.Average vas-score of 1.5+/-0.5 points.Average constant-murley-score of 95.3 +/- 3.9 points.This report is for one (1) device- an unknown synthes titanium elastic nail.This is report 2 of 2 for (b)(4).A copy of the literature article is being submitted with this medwatch.

• 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: 7924086
• MDR Text Key: 122301904
• Report Number: 8030965-2018-56884
• 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: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2018
• 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: 09/06/2018
• 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