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

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

Patient Problems Irritation (1941); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Identifier, age, gender, weight not reported.Jones, clifford b.Md and sietsema, debra l.Phd."analysis of operative versus non-operative treatment of displaced scapular fractures" clinical orthopaedics and related research (2011) 469:3379-3389 united states article.This report is for unknown quantity for unknown schantz pin.Device is unavailable for return.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.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, jones, clifford b.Md and sietsema, debra l.Phd."analysis of operative versus non-operative treatment of displaced scapular fractures" clinical orthopaedics and related research (2011) 469:3379-3389 united states article.A retrospective review of 182 patients with 182 scapular fractures treated between 2002 and 2005 was studied.Of the 182 fractures, 31 were treated with open reduction internal fixation and 31 patients were treated nonoperatively.All patients were followed to time of healing and discharge (14-32 months).The fracture fragments were reduced with 2.5 mm threaded schantz pins inserted into the posterior aspect of the gleoid neck and lateral border freely or in combination with a small external fixator.The fixator attachment maintained the fixation.Presence of wound problems and deep infection, malunion, non-union, nerve injury, rotator cuff weakness, shoulder stiffness or cosmesis were identified but not specifically linked to the open reduction fixation procedure.One (1) patient in the surgically treated group had persistent pain as well as three (3) patients had hardware irritation, two of which had the implants removed.This is report 1 of 2 for (b)(4).This report is for unknown schantz pin.

• 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: 6507011
• MDR Text Key: 73234360
• Report Number: 2520274-2017-11407
• 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,litera
• 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

• 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
• Initial Date Manufacturer Received: 03/27/2017
• Initial Date FDA Received: 04/20/2017
• 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