MAUDE Adverse Event Report: SYNTHES USA; PIN,FIXATION,SMOOTH

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment not diagnosis.This report is for an unknown ao external fixator pin.(other number) udi: unknown part number, udi is unavailable.Investigation could not be completed and no conclusion could be drawn, as no devices were returned and no lot numbers or part numbers were provided.(b)(4).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 subsequent review of the following journal article: lakkireddy, m.(2016) osteosynthesis in distal radius fractures with conventional bridging external fixator; tips and tricks for getting them right.Journal of clinical and diagnostic research, vol-10(1), pp:05-08.The purpose of this study was to study the management of distal end radius fracture by utilizing the principle of ligamentotaxis where in the reduction obtained by closed means is maintained by external fixator till solid bony union occurs.Total of 26 cases between the ages of 18 and 75 years were selected for study by scrutiny of the inclusion and exclusion criteria.Most of our cases were treated with external fixator within 8 hours of injury.Small a.O external fixator (bridging ex-fix) with 2 pins each in radius and 2nd metacarpal percutaneously was used for all the cases.All patients were followed up with for an average of 9 months.One case had complex regional pain syndrome which resolved in 2 months with rigorous physical therapy and medication.One case had superficial pin tract infection which resolved with local wound care and antibiotics.Three cases (11.53%) had wrist stiffness.Marked improvement was seen after two weeks of physiotherapy.Malunion was seen in 2 cases (7.69%), which was primarily due to inability to correct the dorsal angulation.One case had pin tract infection/loosening.This report is for an unknown ao external fixator pin.A copy of the literature article is being submitted with the medwatch.This report is 3 of 3 for (b)(4).This medwatch wil address one case had pin tract infection/loosening.

• Type of Device: PIN,FIXATION,SMOOTH
• 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: 6457341
• MDR Text Key: 71685139
• Report Number: 2520274-2017-11188
• Device Sequence Number: 1
• Product Code: HTY
• 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: Health Professional
• Type of Report: Initial
• Report Date: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2017
• Initial Date FDA Received: 04/04/2017
• 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