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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Necrosis (1971); Injury (2348); Impaired Healing (2378)
Event Type  Injury  
Manufacturer Narrative
There are multiple patients. All known information is provided in the journal article. This report is for unknown multiloc humeral nails/unknown lot. Part and lot number are unknown; udi number is unknown. There are multiple unknown dates of implantation between september 1, 2010 and september 1, 2013. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).
Event Description
This report is being filed after the review of the following journal article: kilian, m. Et al. (2016), surgical versus non-surgical treatment for 3- and 4-part proximal humerus fractures, surgery outlook, volume 95, no. 2, pages 60¿68 (slovakia). The aim of this prospective study was to monitor patients with 3- and 4-part fractures of the proximal humerus who underwent surgical treatment and to compare their results with a control group of 3- and 4-part fractures treated conservatively. Between september 1, 2010 and september 1, 2013, a total of 20 (13 female, 7 male, mean age of 60. 9 ± 7. 67 years) patients with 3- and 4- part neer iv, v and vi proximal humerus fractures were included in the study. 18 patients were treated with either an unknown synthes lcp 3. 5mm plate or an unknown synthes philos plate, while 2 patients were treated with intramedullary fixation using anterograde introduced nail (multiloc humeral nail ¿ synthes). Patients were followed-up 10-14 days, 6 weeks, 3 months, 6 months, 12 months after surgery and whenever needed. The article does not specify with which plate and nail (2 patients treated with) the complications reported were associated. The following complications were reported: an (b)(6) year-old female had deep infection was treated with repeated hospitalizations and a long-term outpatient clinic visits for a total of 6 months. 1 case of screw perforation in 3-part neer v. 1 case of screw perforation in 3-part neer iv. 1 case of screw perforation in 4-part neer vi. 1 case of screw perforation in 4-part. 1 case of centering of screw in 3-part neer iv. 2 cases of centering of screws in 4-part. 1 case of centering of screw in 4-part neer vi. 1 case of false joint in 3-part neer iv. 1 case of infection in 4-part. 2 cases of avascular necrosis in 4-part. 1 case of ulnar nerve injury in 3-part neer iv. 1 case of plexus brachialis injury in 4-part neer vi. 1 case of algoneuro-dystrofia in 3-part neer iv. 7 patients had moderate pain. 3 patients had severe shoulder pain. This report is for unknown synthes multiloc humeral nails. This is report 6 of 6 for (b)(4).
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Manufacturer (Section D)
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
MDR Report Key8374671
MDR Text Key137286578
Report Number8030965-2019-61483
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeLO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 02/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2019
Is this an Adverse Event Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/19/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/27/2019 Patient Sequence Number: 1