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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: MULTILOC HUMERAL NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH UNK - CONSTRUCTS: MULTILOC HUMERAL NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Necrosis (1971); Nerve Damage (1979); Non-union Bone Fracture (2369); Post Operative Wound Infection (2446)
Event Type  Injury  
Manufacturer Narrative
Additional narrative: 510k: this report is for an unknown multilock humeral nail constructs/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k number is unknown. 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.
 
Event Description
This report is being filed after the review of the following journal article: boyer, p. Et al. (2021), displaced three and four part proximal humeral fractures: prospective controlled randomized open-label two-arm study comparing intramedullary nailing and locking plate, international orthopaedics, vol. 45, pages 2917-2926 (france). The aim of this study was (1) to compare clinical and radiological outcomes of 3- and 4-part proximal humeral fractures using either imn or lp (2) and to report complications related to each technique. Between january 2012 and december 2015, a total of 99 patients underwent surgical procedure for 3- and 4-part proximal humeral fractures. 50 patients underwent a locking plate procedure and 49 patients underwent an imn procedure using a straight humeral nail (multiloc nail, depuy synthes, warsaw, usa). The mean age was 73. 7 years (± 13. 3,, and the mean follow-up was 66 months. The following complications were reported as follows: 1 patient died. 2 patients had nonunion which was revise with rsa and reaming + imn. 2 patients had avascular necrosis which was revised with rsa. 2 patients had humeral impingement which required hardware removal. 1 patient had an infection which was washed-out. 2 patients had screw cut-through which required removal. This report is for an unknown synthes multiloc nail constructs. This report captures the reported 2 patients who had nonunion which was revise with rsa and reaming + imn, 2 patients who had avascular necrosis which was revised with rsa, 2 patients who had humeral impingement which required hardware removal and 1 patient had an infection which was washed-out. A copy of the literature article is being submitted with this medwatch. This is report 1 of 2 for (b)(4).
 
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Brand NameUNK - CONSTRUCTS: MULTILOC HUMERAL NAIL
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key13874061
MDR Text Key293158421
Report Number8030965-2022-01840
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/24/2022 Patient Sequence Number: 1
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