MAUDE Adverse Event Report: SYNTHES (USA); PIN, FIXATION, THREADED

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal article, ¿surgical treatment of proximal humeral fracture with external fixator¿ (2012).Ebraheim, n., lause, g., and zhang, j.Journal of shoulder and elbow surgery; 21, 882-886.In this retrospective study, 32 sequential displaced proximal humeral fractures underwent surgical treatment at an institute between march 2007 and june 2009.There were 22 men and 10 women.The mean age of the patients was 56 years (range, 23-81 years).Patients were treated with 4 threaded pins (diameter, 3mm; synthes, solothurn, switzerland) were inserted percutaneously into the humeral head with the tip of the needle located at 3mm under the articular surface.The pins of the mini-external fixators (synthes) were cleaned 3 times a day with alcohol and removed at 6 or 8 weeks postoperatively when signs of fracture union could be seen on the radiographs.The pin removal was performed in an outpatient setting.Two patients had loosening of the pins which required an unplanned second operation within 12 months after the initial operation.The patients underwent hemiarthroplasty eventually.This is 2 of 2 reports for (b)(4).This report is for unknown 3mm threaded pins.

Manufacturer Narrative

¿surgical treatment of proximal humeral fracture with external fixator¿ (2012).Ebraheim, n., lause, g., and zhang, j.Journal of shoulder and elbow surgery; 21, 882-886.This report is for an unknown 3mm threaded pins/unknown quantity/unknown lot.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.

• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4115523
• MDR Text Key: 4840659
• Report Number: 2520274-2014-13678
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• 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
• Date Manufacturer Received: 09/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention