MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; PLATE, FIXATION, BONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Arthritis (1723)

Event Type  Injury  

Manufacturer Narrative

Twenty-one (21) patients (12 males and 9 females) with mean age of 37.1 years (range, 21-53 years).Date of event: unknown.Implant date: unknown.Explant date: unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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.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: liu, h.Et al (2017), surgical management of hawkins type iii talar neck fracture through the approach of medial malleolar osteotomy and mini-plate for fixation, journal of orthopaedic surgery and research, vol.12(111), pages 1-9 (china) the purpose of this retrospective study is to investigate the surgical treatment strategy of hawkins type iii talar neck fractures through approach of medial malleolar osteotomy and mini-plate for fixation and to assess the therapeutic effects after long-term follow-up.Between january 2010 and january 2015, 21 patients (12 males and 9 females) with mean age of 37.1 years (range, 21-53 years) underwent medial malleolar osteotomy and mini-plate fixation.The injured chondral surface and fracture was fixed using unknown synthes mini-screws and unknown synthes mini-plate.Hawkins score consists of three parts: pain, the presence of a limp, and range of motion of the ankle.Pain was assigned from 0 to 6 points: no pain as 6 points, pain only after fatigue as 3 points, and pain after walking as 0 point.The presence of limp ranged from 0 to 3 points: 3 points for no limp and 0 point for the presence of a limp.The ranges of motion of the ankle and subtalar joint were rated from 0 to 3 points, respectively: full motion as 3 points, partial motion as 2 points, and the fixed deformity as 0 point.Overall, ¿excellent¿ was classified as a cumulative score of 13 to 15, ¿good as 10 to 12, ¿fair¿ as 7 to 9 and ¿poor¿ as 6 or less.The american orthopaedic foot and ankle society (aofas) ankle-hindfoot score was also used to assess functional outcome.The functional results were obtained regularly postoperatively.Follow-up was conducted between 18 and 41 months post-operation, with an average of 29.6 months.The following complications were reported: a (b)(6) male patient presented with a right ankle injury due to fall from a 4 m height.Patient underwent fixation using unknown synthes mini-screws and unknown synthes mini-plate.Patient presented with talocrural arthritis and partial avn of the talar bones after 3 2 years follow-up.Satisfactory range of motion was achieved at 2 years follow-up.This report is for an unknown synthes mini-plate.This is report 3 of 6 for (b)(4).

• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7681772
• MDR Text Key: 113778560
• Report Number: 8030965-2018-54970
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2018
• 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 Age: 49 YR