MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: PLATE/SCREWS: CALCANEAL; PLATE, FIXATION, BONE

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

Patient Problems Impaired Healing (2378); Skin Inflammation/ Irritation (4545)

Event Date 05/30/2023

Event Type  Injury  

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d1, d2, d3, d4, g4 ¿ 510k: this report is for an unknown construct: plate/screws: calcaneal/unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: 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: y cheng, et al (2023)/a comparison of treatment between mini t-plate and headless cannulated compression screw in calcaneal osteotomy, international orthopaedics 47, pages 1995-2001 (china).This study aims to compare the clinical outcome of mini t-plate and headless cannulated compression screws in calcaneal osteotomy.Between (b)(6) 2021 a total of 39 patients (17 male and 22 female); 22 were fixed using a mini t-plate through a modified small incision "l" incision on the lateral aspect of the calcaneus and 17 were fixed using double 6.5mm headless cannulated compressed screws.The average age was 49.23 +- 13.80 (range:24-76) years and the average follow-up duration was 47.07+-8.64 (range:36-66) weeks.The following complications were reported as follows: mini t-plate group: 1 patient had fixation removed.This may be caused by the irritation of the plate.The patient often felt uncomfortable at the surgical site and the symptoms disappeared after the removal of the internal fixation.2 patients had delayed healing of the incision.The main manifestation was continuous bleeding of the wound and the healing time exceeded to weeks.After continuous dressing change the surgical incisions were completely healed at three weeks after operation.Double screws group: 6 patients had their internal fixation removed.Patients complained of posterior heel pain after walking for a long time.4 patients experienced hardware-related pain, with one patient's symptoms disappearing after conservative treatment and three patients showing improvement after removal of the screws.1 patient presented with delayed healing of the lateral calcaneal incision.This may be related to the patient's hyperglycemia and the wound healed after continuous dressing change.1 patient presented with clinical neurological complications at the incision site.The main clinical manifestation was numbness around the incision.A copy of the literature article is being submitted with this medwatch.This report is for an unk - construct: plate/screws: calcaneal.This is report 1 of 2 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS: CALCANEAL
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18496114
• MDR Text Key: 332723566
• Report Number: 8030965-2024-00732
• 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: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• 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: 12/19/2023
• 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