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

Device Problem Unstable (1667)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Blum, j., rommens, p., janzing, h., and langendorff, h.(1998).Retrograde nagelung von humerusschaftfrakturen mit dem uhn fine internationale multizentrische studie (retrograde nailing of humerus shaft fractures with the unreamed humerus nail.An international multicenter study).Der unfallchirurg, 101, 342-352.This report is for an unknown locking 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.

Event Description

This report is being filed after subsequent review of the following literature article: blum, j., rommens, p., janzing, h., and langendorff, h.(1998).Retrograde nagelung von humerusschaftfrakturen mit dem uhn fine internationale multizentrische studie (retrograde nailing of humerus shaft fractures with the unreamed humerus nail.An international multicenter study).Der unfallchirurg, 101, 342-352.The unreamed humeral nail (uhn) was used was used during the reduction and fixation of humeral shaft fractures.This is a multicenter report that analyzes 102 retrograde nailings with the uhn.Patients were 59 men and 53 women with humeral shaft fractures.The mean age was 54.9 years, with ages ranging from 16 to 99 years old.75 patients were followed until healing.The mean age of these 40 men and 35 women was 56.1 years, the youngest patient was (b)(6), the oldest patient was (b)(6) old.Seventy-five patients could be followed until bone healing.Seventy-three fresh humeral shaft fractures, 12 pseudoarthrosis, 3 refractures and 14 pathological fractures were treated with the uhn.In the 73 reported recent fractures, four were severe, closed soft tissue injuries and seven fractures were open.In 12 patients, there were multiple musculoskeletal injuries, 13 patients with polytrauma and 14 patients with pathological fractures.At the time of admission, one patient had brachial plexus paresis, six patients had primary radial nerve paresis and one had median nerve paresis.Complications included: there was a report of insufficient instability of locking pins.This is report 2 of 2 for (b)(4).This report is for an unknown locking pins.

• Type of Device: PIN, FIXATION, SMOOTH
• 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: 5153029
• MDR Text Key: 28378376
• Report Number: 2520274-2015-16674
• 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: Other
• Type of Report: Initial
• Report Date: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/07/2015
• 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