MAUDE Adverse Event Report: SYNTHES USA; APPLIANCE, FIXATION, NAIL

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

Patient Problems Damage to Ligament(s) (1952); Nerve Damage (1979); Pain (1994); Non-union Bone Fracture (2369); Joint Dislocation (2374); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Midterm results of 58 fractures of the coronoid process of the ulna and their concomitant injuries.The open orthopaedics journal, volume 7, pp.86-93.(2013).This report is for unknown external fixation devices, unknown quantity, unknown lot.(b)(4): revision surgery, compartment syndrome, joint mice, pseudarthroses of the ulna, joint instability, worsened mobility.The investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number or part number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Literature article received : this report is being filed after the subsequent review of the following literature article: kiene, j., waldchen, j., paech, a., jurgens, ch., schulz, a.P.(2013).Midterm results of 58 fractures of the coronoid process of the ulna and their concomitant injuries.The open orthopaedics journal, volume 7, pp.86-93.Germany.The purpose of the study was to prognostically determine relevant factors for the therapy recommendation to treat fractures of the coronoid process.The study was conducted over an 8 year period from 2001 to 2009 and included seventy seven (77) patients (41 female, 36 male) with an age range of 15-79 years (mean age of 51.8 years).The fractures were treated with a combination of unknown screws, unknown mini plates, lasso slings, ossceous replacement, and isolated fragment resection.A total of twenty three (23) patients were treated with unknown synthes external fixation devices.The following complications were reported: - 15 patients treated with external fixation devices needed revision surgery; - 7 patients not treated with external fixation devices needed revision surgery; - 10 partial or complete nerve lesions were noted postoperatively; - compartment syndrome; - joint mice; - pseudarthroses of the ulna; - non-union; - persistent luxations requiring complete elbow joint prosthesis; - ligament damage; - pain ranging from slight to severe depending on the load; - joint instability; - worsened mobility.This is report 1 of 1 for (b)(4).This report is for an unknown external fixation device.

• Type of Device: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6511810
• MDR Text Key: 73384362
• Report Number: 2520274-2017-11449
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• 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?: No
• Date Manufacturer Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention