MAUDE Adverse Event Report: SYNTHES (USA); NAIL, FIXATION, BONE

Device Problem Positioning Problem (3009)

Patient Problem Reaction (2414)

Event Type  malfunction  

Event Description

This report is being filed after the subsequent review of the following journal article: hessmann, m.Et al (2012, september).Internal fixation of fractures of the proximal humerus with the multiloc nail.Operative orthopadie und traumatologie, 24 (4-5), pp.418-431.Surgical technique was reported with the use of the synthes devices, multiloc humeral nail and screw, to reduce two to four part fractures of the proximal humerus.An endcap, manufacturer not specified, was also captured since the devices mentioned in this article are those of this manufacturer.The authors studied 160 patients, mean age of 65.5 years, during a six month period.Early complications included implant-related impingement and loosening of proximal locking screws in one case each.A six month follow-up was conducted with 17 patients, mean age of 67.2 years.Loss of reduction and intra articular screw penetration were reported in one case each.Radiographically, all fractures had healed.This is a reportable malfunction report for one patient with implant- related impingement.This is report 2 of 8 for complaint (b)(4).This report is for an unknown nail.

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for an unknown nail.Implant date: date unknown.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: NAIL, FIXATION, BONE
• 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: 3679842
• MDR Text Key: 4295613
• Report Number: 2520274-2014-10266
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Initial Date Manufacturer Received: 02/16/2014
• Initial Date FDA Received: 03/14/2014
• 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