MAUDE Adverse Event Report: SYNTHES (USA); BOLT, NUT, WASHER

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 12/20/2014

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment not diagnosis.This report is for an unknown midfoot fusion bolt.(b)(4) revision surgery.Device loosening.Investigation could not be completed and no conclusion could be drawn, as no devices were returned and no lot numbers or part numbers were provided.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 subsequent review of the following journal article: wurm, m et al.The midfoot fusion bolt: a new perspective? (2014) orthopade, 44:65-70.The aim of this study was to investigate short-term results including complications and review published surveys.A total of 16 patients were included in this study where the midfoot fusion bolt (depuy synthes, (b)(4)) was used to treat midfoot charcot.Foot disease.The bolts were used on an average of 21.17 months in 16 patients and 17 feet.Between 2009 and 2014, six bolts had to be removed.In 2 cases, the bolts were removed at the patients request, in the other 4 cases; the bolts were removed due to loosening.4 cases experienced postoperative ulcerations, 2 of these cases healed postoperatively, while the other 2 cases led to amputation due to infections and chronic osteomyelitis.As other complications, two talus necroses should be mentioned.The average fusion rate was 92.35 percent.In the aftercare period, two patients died, but no relationship whatsoever was established with charcot foot disease.This is report 2 of 2 for (b)(4).This report is for an unknown midfoot fusion bolt.This medwatch addresses 4 cases where the bolts were removed due to loosening.

• Type of Device: BOLT, NUT, WASHER
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5771637
• MDR Text Key: 48821222
• Report Number: 2520274-2016-13359
• Device Sequence Number: 1
• Product Code: HTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Initial Date Manufacturer Received: 06/20/2016
• Initial Date FDA Received: 07/06/2016
• 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