MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAIL HEAD ELEMENTS: MULTILOC HUMERAL SCREW; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Brand name, common device name, manufacturer name, city and state, lot #, pma/510k: this report is for an unknown multilock humeral nail screws/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Device evaluation by mfr and manufacturer date: 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 screws.This report captures the reported 2 patients who had screw cut-through which required removal.This is report 2 of 2 for (b)(4).

• Brand Name: UNK - NAIL HEAD ELEMENTS: MULTILOC HUMERAL SCREW
• Type of Device: ROD, 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 Key: 13874070
• MDR Text Key: 293158949
• Report Number: 8030965-2022-01841
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• 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: 03/09/2022
• 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