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

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not for diagnosis.Richter, m; et al (2015) intramedullary fixation in severe charcot osteoneuroarthropathy with foot deformity results in adequate correction without loss of correction ¿ results from a multi-centre study.Foot and ankle surgery, 805: 8 pages.This report is for an unknown midfoot fusion bolt (unknown quantity/unknown lot).(b)(4).The investigation could not be completed; no conclusion could be drawn, as no device was returned and no lot number or part number was 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 subsequent review of the following article: richter, m; et al (2015) intramedullary fixation in severe charcot osteoneuroarthropathy with foot deformity results in adequate correction without loss of correction - results from a multi-centre study.Foot and ankle surgery, 805: 8 pages.Charcot osteo-neuroarthropathy (cn) of the feet can induce severe instability and deformity with subsequent plantar ulceration.Leading to substantial disability or even amputation.Traditionally, nonoperative treatment is regarded as the primary option of treatment while surgery is restricted to treating complications or failure of non-operative treatment.Early postoperative period, problems occur frequently due to inadequate correction, unstable internal fixation and especially loss of correction , which are associated both with the different types of internal fixation (using plates, staples and screws) and/or external fixation.Intramedullary fixation with solid bolts (midfoot fusion bolt (mfb), synthes (b)(4)) has been introduced as an option for fixation with high stability.The study was carried out as multi-centre study in three locations for forty-seven patients from april 2009 to june 2013.Mean patient age at the time of surgery was 60.1 years.Twenty-eight patients were male.Mean height was 173.7 cm, mean weight 95.4 kg.The left foot was treated in 19 patients, the right foot in 27 patients, and both feet in 1 patient, resulting in 48 treated feet.The patient with bilateral involvement was treated with an 8-month interval between correction of the first and second foot.In a total of 27 feet three mfbs were inserted, in 6 feet two mfbs were inserted, and for 15 feet one mfb was used.Adverse events reported for mfb were loosening in 3 patients, breakage in 1 patient and non-union in 2 patients.In conclusion, fixation with mfb in severe charcot osteoneuroarthropathy results in adequate correction without loss of reduction in 94% during the first 1-2 years after surgery.The nonunion rate of 2% at final follow-up was lower than reported previously.This implies that stable fixation with mfb is a viable treatment option for cn that prevents loss of correction and provides high union rates.This report is 1 of 2 for (b)(4).This report is for an unknown midfoot fusion bolt (mfb) and refers to the reportable malfunction for 3 unknown patients who experienced loosening and 1 unknown patient who experienced breakage.

• Type of Device: BOLT, NUT, WASHER
• 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: 5116141
• MDR Text Key: 27214134
• Report Number: 2520274-2015-16362
• 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
• Report Date: 09/23/2015

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2015
• 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