MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS: TRAUMA; SCREW,FIXATION,BONE

Device Problem Unintended Movement (3026)

Patient Problems Fatigue (1849); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

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, 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.(b)(4).

Event Description

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: de pellegrin, m.Et al (2014), subtalar extra-articular screw arthroereisis (sesa) for the treatment of flexible flatfoot in children, journal of children's orthopaedics, vol.8 (6), pages 479-487 (italy).The aim of this study is to describe this technique, referred to as the subtalar extra-articular screw arthroereisis (sesa) technique, and to analyse the outcomes.Between 1990 to 2012, a total of 485 patients (267 male and 218 female) with a mean age of 11.5 ± 1.81 years (range 5.0¿17.9 years; median 11.5 years).Surgery was performed using an ao cancellous screw or cannulated screw.All patients were clinically evaluated at pre-determined post-operative time-points: 5, 11 and 30 days; 3 and 6 months; 1 and 2 years; at the time of screw removal; 1 year following screw removal.The average follow-up was 4.5 (range 3.1¿13.2) years.The following complications were reported as follows: of the 16 percent who had fatigue pre-sesa, 3 percent remained as is 3 months post-sesa.Of the 11 percent who had pain pre-sesa, 2 percent remained as is 3 months post-sesa.Of the 8 percent who had tripping pre-sesa, the number increase to 49 percent 3 months post-sesa.Of the 67 percent who had orthoses pre-sesa, 11 percent remained as is 3 months post-sesa.15 percent had forefoot abductus 3 months post-sesa.7 percent had varus hindfoot 3 months post-sesa.14 patients had contracture of the peroneal muscles due to an antalgic position in pronation.These patients required two injections of methylprednisolone acetate (1 ml) locally at the level of the screw head to obtain symptom resolution.3 patients had pain along the lateral border of the midfoot but were revealed to have a stress fractures of the fourth metatarsal bones due to abnormal gait with excessive weight-bearing on the fourth to fifth rays that were all healed upon x-ray.6.3 percent had a poor outcome (table 3).2 patients had a loss of correction, the indication to substitution (n = 1) and to regularisation (n = 1) was given for abnormal growth of the foot with a loss of the mechanical effect of the screw.8 patients had ankle joint effusion or haemarthrosis, in absence of acute inflammatory signs, with an important decrease in the range of motion and painful weightbearing.They were treated with early removal of the screw (average 8 months post-sesa) when conservative treatment had been unsuccessful.At revision surgery, it became apparent that during the intraoperative period all patients had an osteolysis of the talus lateral process (where there was contact with the screw¿s head).A new screw was successfully implanted in two patients 1 year later, one patient was treated elsewhere, and five patients did not undergo further surgery and the correction therefore obtained remained partial.This report is for an unknown synthes screws.A copy of the literature article is being submitted with this medwatch this report is for 2 of 2 for (b)(4).

• Brand Name: UNK - SCREWS: TRAUMA
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester 19380 ; 6103142063
• MDR Report Key: 9227016
• MDR Text Key: 176596167
• Report Number: 8030965-2019-69579
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/09/2019

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2019
• Initial Date FDA Received: 10/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention