MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - NAILS: MULTILOC HUMERAL; ROD, FIXATION, INTRAMEDULLARY

Device Problems Break (1069); Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Date 02/19/2020

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown nails: multiloc humeral/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.(b)(4).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: dauwe, j.Et al.(2020).Osteosynthesis of proximal humeral fractures: a 1-year analysis of failure in a belgian level-1 trauma centre, european journal of trauma and emergency surgery, vol.Xx, page xx (belgium).The aim of this study was to perform a retrospective patient record analysis over 1 year to calculate the failure rate at the university hospitals of leuven, a belgian level-1 trauma centre.Furthermore, different (fracture unrelated) variables were taken into account to predict the failure of osteosynthesis after phf.From january 2017 to january 2018, a total of 134 patients (47 males and 87 females) were treated with angular stable osteosynthesis using a philos plate (ao synthes gmbh, oberdorf, switzerland), an alps plate, zimmer-biomet, warsaw, usa) and a multiloc proximal humeral nail (ao synthes gmbh, oberdorf, switzerland).The following complications were reported as follows: 21 cases of the proximal humeral osteosynthesis failed.6 patients needed a reoperation because of non-union.4 patients had to be revised because of infection.11 patients were revised because of other causes.(loosening or breakage of the implant, screw pull-out and screw penetration.) this report is for a unknown multicloc proximal humeral nail.This is report 4 of 5 for (b)(4).

• Brand Name: UNK - NAILS: MULTILOC HUMERAL
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9944188
• MDR Text Key: 193620667
• Report Number: 8030965-2020-02760
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• 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: 04/06/2020
• 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