MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: FOOT; BONE PLATE

Catalog Number UNK - PLATES: FOOT

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

Patient Problems Arthritis (1723); Bone Fracture(s) (1870); Nerve Damage (1979); Pain (1994); Non-union Bone Fracture (2369); Ambulation Difficulties (2544); Joint Laxity (4526); Malunion of Bone (4529); Unspecified Tissue Injury (4559); Physical Asymmetry (4573)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: sethuraman s., et al (2022) radiographic outcomes of cortical screw fixation as an alternative to kirschner wire fixation for temporary lateral column stabilization in displaced lisfranc joint fracture dislocations: a retrospective cohort analysis, bmc musculoskeletal disorders volume 23:pages 51-54 (usa).This retrospective cohort study aims to evaluate the efficacy of temporary lateral column cortical screw fixation as an alternative to k-wire fixation for tmt joint fracture-dislocations.From 2005 to 2018, 45 consecutive patients who underwent osseous fixation of lisfranc joint fracture-dislocations (myerson classification types a, b1, b2, c1, and c2) was reviewed.Thirty-one patients met inclusion criteria for this study with ages ranging from eighteen to 73 years old (mean age 39.8 ± 15.9 years).Five patients were further excluded from analysis.Twenty six patients remained eligible for analysis.Mean age for these patients was 41.0 ± 16.9 years.All patients underwent medial and middle column fixation with 3.5 mm cortical screws (synthes, (b)(4)) and 31 also underwent lateral column fixation either with 3.5 mm cortical screws or 0.062-in.Kirschner wires (synthes, (b)(4)).Patients were treated according to senior author preference for lateral column fixation method.3.5 mm or 2.7 mm plates (synthes, (b)(4)) were also used in medial column fixation constructs for fourteen patients.The primary outcome measure was radiographically stable lateral column healing before and after implant removal.Mean follow-up was 88.2 ± 114 weeks for all patients.Reported complications: those with k-wire fixation of the lateral column were more likely to suffer from disuse osteopenia.Two patients in the k-wire cohort required a cane for ambulatory assistance due to peroneal palsy and ipsilateral cuboid and talus fractures, respectively.4 patients that underwent lateral column k-wire fixation were more likely to complain of post-operative pain.Fig.3 an anteroposterior, oblique, and lateral injury radiographs of the left foot demonstrating myerson type a laterally incongruous tmt joint fracture-dislocation.B anteroposterior, oblique, and lateral postoperative radiographs demonstrating restoration of anatomic alignment of midfoot, medial column tmt joint primary arthrodesis, and lateral column k-wire fixation.C anteroposterior, oblique, and lateral postoperative radiographs demonstrating removal of lateral column k-wires and mild narrowing of fourth and fifth tmt joint.Longitudinal clinical outcomes of patients that received lateral column fixation via k-wire constructs: 6 post-traumatic arthritis.9 disuse osteopenia.4 aided mobility.Longitudinal clinical outcomes of patients that received lateral column fixation via cortical screw: 7 post-traumatic arthritis.5 disuse osteopenia.1 aided mobility.1 did not return to normal shoe wear,one patient in the cortical screw cohort required a one-inch heel lift post-operatively.Longitudinal radiographic outcomes of patients that received lateral column fixation via cortical screw: 2 unstable hardware.1 non-healing fracture.13 hardware removed.5 staged hardware removal.Longitudinal radiographic outcomes of patients that received lateral column fixation via k-wire constructs: 2 unstable hardware.11 hardware removed.2 staged hardware removal.This report involves one unknown synthes 3.5 mm or 2.7 mm plates.This is report 2 of 3 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.510k: this report is for an unknown synthes 3.5 mm or 2.7 mm 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.Product was not returned.Based on the information available, it has been determined that no corrective and 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 - PLATES: FOOT
• Type of Device: BONE PLATE
• 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: 15390786
• MDR Text Key: 299562363
• Report Number: 8030965-2022-06579
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

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
• Device Catalogue Number: UNK - PLATES: FOOT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 09/09/2022
• 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