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

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Non-union Bone Fracture (2369); Post Operative Wound Infection (2446); Unspecified Tissue Injury (4559); Physical Asymmetry (4573); Swelling/ Edema (4577); Insufficient Information (4580)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: kabelitz, m.Et al (2023), two-staged management of ankle fracture-dislocations with a posterior fragment: computer-tomography-based classification, treatment and its outcome, archives of orthopaedic and trauma surgery xx.Xx.Pages 1-8 (switzerland).The aim of this study was to retrospectively describe the functional outcome after a two-stage operative stabilisation including direct fixation of the posterior fragment in trimalleolar dislocation fractures.Between 2008 and 2019 of 320 trimalleolar dislocation fractures, a total of 39 patients (12 male and 27 female), a mean age of 60 years was included in the study.Fixation was executed based on bartonícek's fracture classification: for type 2 fractures n=15, (13 cases) were treated using a 3.5 mm third-tubular locking compression plate (lcp), (1 case) with a 2.7/3.5 mm variable-angle (va)-lcp), and (1 case) with a 3.5 mm tibial lcp; for type 3 fractures n=9, (7 cases) were fixed with 3.5 mm third-tubular plate, (1 case) with 2.4/2.7 mm va-lcp, and (1 case) with 3.5 mm tibial lcp; and for type 4 fractures n=15, (9 cases) were fixed with a 3.5 mm third-tubular plates, (3 cases) with two 3.5 mm lag screws, (1 case) with a 2.7/3.5 mm va-lcp, and (2 cases) fixed with a 2.7 mm distal tibial va-lcp.All patients had a mean follow-up of 49 months.The following complications were reported as follows: 1 patient had irritation, considering removal; implant not removed, 7 patients had implant removed routinely or on patients request without irritation.18 patients had implant removed due to implant irritation infection.3 patients had superficial infection in the operation site; infections were treated conservatively.1 patient had deep infection in the operation site.One patient developed a deep infection of the lateral malleolus 6 weeks.Postoperative and was treated with wound revision and prolonged antibiotic therapy.1 patient had delayed-union.3 patients had re-operation for problems with the osteosynthesis.1 case for a persistent fibula shortening with consecutive lateral shift of the talus had to be correct with re-osteosynthesis of the fibula.1 case which showed a relevant malreduction of the typical intermediate fragment, which led to an incongruence of the tibial articular surface and had to be revised with reosteosynthesis in a second step.1 case developed a deep infection of the lateral malleolus 6 weeks postoperative and was treated with wound revision and prolonged antibiotic therapy.Finally, after osseous consolidation, an early hardware removal of the fibula plate 2.5 months after the index surgery was done to control the infection.4 patients presented an open fracture with a severe soft tissue damage: treated with wound vacuum therapy, partial wound closure and after further improvement of the swelling final application of a split-thickness skin graft.This report is for an unknown 3.5 mm third-tubular plate synthes, unknown 2.7/3.5 mm variable-angle va lcp synthes, unknown 3.5 mm tibial lcp synthes, unknown 2.4/2.7 mm va-lcp synthes, and unknown 2.7 mm distal tibial va-lcp synthes.A copy of the literature article is being submitted with this medwatch.This is report 1 of 1 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 lcp constructs/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.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: LCP
• 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: 18722258
• MDR Text Key: 335700574
• Report Number: 8030965-2024-02599
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 02/16/2024
• 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: 02/07/2024
• 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