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

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

Patient Problems Pulmonary Embolism (1498); Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: oransky, m.Et al.(2022) endosteal plating for the treatment of malunions and nonunions of distal femur fractures, european journal of orthopaedic surgery & traumatology, vol.Xx (xx), pages 1-9 ( italy ).The aim of this observational retrospective study was to describe the surgical technique and the outcome of a case series of nonunion and malunion of distal femur fractures treated with an endosteal medial plate combined with a lateral locking plate and with autogenous bone grafting.Between january 2011 and december 2019, a total of 10 patients (7 male and 3 female) with mean age of 48.3 years (range 21¿67) were included in the study.The intramedullary plate (4.5 mm tibial dcp or locking compression plate depuy synthes) was associated on the lateral side with a condylar blade-plate (cbp, depuy synthes) in 8 patients, with a liss plate in 1, and with a lcp condylar plate 4.5/5.0 (lcp¿cp, depuy synthes) in another.Bone graft was obtained using ria (reamer-irrigator-aspirator; de puy synthes) from the contralateral femur in 9 patients, while patient had bone grafting from posterior iliac crest.The mean follow-up was 13.5 months.The following complications were reported as follows: 3 patients were not completely corrected in preoperative shortening and had residual shortening of 1-2 cm: a 52 year old male, a 21 year old female and a 65 year old male patients.A 50 year old male had unsuccessful treatment with the c2 open fracture who also had a concomitant colon adenocarcinoma with hepatic metastasis that died 12 months after the initial treatment.In this case, the blade plate failed at six months after surgery; also had pulmonary embolism this report is for an unknown synthes plate and screws.A copy of the literature article is being submitted with this medwatch.This is report 2 of 2 for (b)(4).

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.D1, d2, d3, d4, g4-510k: this report is for an unknown plate and screws/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.E1: initial reporter address : (b)(6) h3, h4, h6: 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.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.

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 18232168
• MDR Text Key: 329319075
• Report Number: 8030965-2023-15013
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• 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: 11/07/2023
• 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
• Patient Age: 50 YR
• Patient Sex: Male