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 Fatigue (1849); Post Operative Wound Infection (2446); Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plates: locking: calcaneal plate/unknown lot.Part and lot numbers are unknown; udi 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: kinner b., et al (2010) calcaneocuboid joint involvement in calcaneal fractures, the journal of trauma® , volume 68, number 5, pages 1192-1199 (germany).This study aims to analyze the incidence of ccj involvement in calcaneal fractures, its mechanism of injury, and its treatment and to compare the outcome to the outcome of calcaneal fractures without calcaneocuboid involvement.Between 2000 and 2004, 151 patients with acute calcaneal fractures were treated.A total of 44 of the 106 patients met the inclusion criteria.Based on the preoperative fracture classification standard, surgical procedures were used: 30 open reductions, lateral plate fixation using the sanders plate, synthes calcaneal locking plate, 2 open reduction using the medial anti-gliding plate, lateral compression screw using the standard or locking small fragment plate, 6 minimally invasive using cannulated 3.5 or 4.5 screws and 6 cannulated 3.5 or 4.5 screws using the k-wire, external fixation.Patients were followed up clinically after an average of 3.5 [1¿5] years.The following complications were reported as follows: only one revision was necessary for deep infection.1 superficial wound infection (ccj not involved), 3 superficial wound infection (ccj involved), 1 deep wound infection (ccj involved), 1 systemic complication (ccj involved), most patients (8 patients without ccj and 19 patients with ccj involvement) had implant removal combined with subtalar arthrolysis, twenty-six percent of the patients showed a postoperative step or gap of more than 2 mm in the ccj which has significant impact on the grade of osteoarthritis detected in the latest follow-up, nine of 30 patients with calcaneocuboid involvement were unable to stand one-legged, whereas only 2 patients without calcaneocuboid involvement were unable to stand one-legged and twenty-three percent of the patients had minor shortening of contact time of the injured foot.This report is for an unknown synthes calcaneal locking plate.

• 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11868824
• MDR Text Key: 265976119
• Report Number: 8030965-2021-04160
• 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: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2021

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: 04/26/2021
• Initial Date FDA Received: 05/23/2021
• 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