MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: LOCKING: CALCANEAL PLATE; PLATE, FIXATION, BONE

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

Patient Problems Loss of Range of Motion (2032); Post Operative Wound Infection (2446); Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown locking calcaneal plates/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is 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.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 available, 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.

Event Description

This report is being filed after the review of the following journal article: hirschmüller, a.Et al (2011), do changes in dynamic plantar pressure distribution, strength capacity and postural control after intra-articular calcaneal fracture correlate with clinical and radiological outcome?, injury, international journal of the care of the injured, vol.42 (xx), pages 1135¿1143 (germany).The aim of this study is to investigate calf muscle strength, postural control and gait biomechanics of patients with healed unilateral intraarticular calcaneal fracture who received standardized surgical treatment at our level 1 trauma center and to correlate the documented findings with initial fracture severity and clinical outcome parameters.Between july 2007 to july 2008, a total of 60 patients (43 male and 17 female) with a mean age of 46.4±13.8 years, who underwent surgical treatment between january 2000 and july 2006, were included in the study.Surgical treatment consisted of open reduction and internal fixation through a standard lateral approach (3.5 mm calcaneus plate, synthes, umkirch, germany).The mean follow-up period was 4.1±2.1 years.The following complications were reported as follows: 10 patients had disturbed wound healing or secondary bleeding.5 patients had complications associated with reposition/osteosynthesis such as implant failure, incorrect screw placement and unsatisfactory reduction.6 patients had postoperative wound infection.12 patients required revision surgery.5 patients needed screw replacement.4 patients required wound debridement.In 2 patients, arthrodesis of the subtalar joint was performed.In an unknown number of patients, the mean reduction in mobility was -15±128 (-24%) for the ankle joint and -70±30% for the subtalar joint.In 3 patients, the range of motion at the talocrural joint was too limited for full testing.In 4 patients pain stopped testing prematurely.6 patients were not able to stand on one leg even on even ground.14 patients had to stop the test after standing on the unstable platform alone without excursions because firm one-leg stance was not possible on the plate.This report is for an unknown synthes locking calcaneal plates.This report captures the reported events of implant failure, unsatisfactory reduction, wound infection, required revision surgery, required wound debridement, underwent arthrodesis of the subtalar joint, mean reduction in mobility was -15±128 (-24%) for the ankle joint and -70±30% for the subtalar joint, range of motion at the talocrural joint was too limited, not able to stand on one leg on even ground or unstable platform and pain.This is report 1 of 2 for (b)(4).

• Brand Name: UNK - PLATES: LOCKING: CALCANEAL PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 11890298
• MDR Text Key: 266423642
• Report Number: 8030965-2021-04323
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• 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
• Date Manufacturer Received: 04/29/2021
• 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