MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: 3.5 MM LCP DISTAL TIBIA T-PLATE; PLATE, FIXATION, BONE

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

Patient Problems Unspecified Infection (1930); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: 510k: this report is for an unknown 3.5-mm locking compression plate t-plate/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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: teuber h, et al.(2021), nonunion after an open trimalleolar ankle fracture: an extended clinical course and a novel approach to tibio-talo-calcaneal arthrodesis, the journal of foot & ankle surgery, volume 60.Pages 378-381, (switzerland) this case report discusses the operative management of an open ankle fracture-dislocation initially managed with open reduction and internal fixation (orif).Chronic osteomyelitis with severe destruction of the ankle joint after failed fracture fixation of an open trimalleolar ankle fracture.The patient was a healthy, nonobese (b)(6) male suffering a third degree open, displaced trimalleolar ankle fracture-dislocation after a motorcycle accident.Initial management included closed reduction and external fixation with irrigation, debridement and negative pressure wound therapy of the ankle.3 days after trauma, the ankle was again irrigated and debrided.After swelling subsided, the trimalleolar fracture was treated with a competitor's neutralization plating and a competitor's lag screw-osteosynthesis and medial soft tissue defect was treated with a microvascular gracilis flap.Postoperative healing was unspectacular with no signs of infection and no flap necrosis.At 6-month follow-up, a nonunion with hardware failure and secondary fracture dislocation due to patient noncompliance with excessive early weightbearing was diagnosed without renewed trauma.An allograft-interposition tibio-talar arthrodesis and revision open reduction and internal fixation with a competitor's plate fixation were performed.Unfortunately, a nonunion persisted and 16 months postoperatively and the competitor's blade plate was removed and a tibio-talo-calcaneal fusion with a competitor¿s arthrodesis nail and reamed tibial cancellous bone augmentation was performed.After an additional 6 months, fusion was not achieved, and a further revision with an unknown synthes ankle-arthrodesis plate medially and an unknown synthes 3.5-mm locking compression plate t-plate laterally after nail removal was performed.Allograft adipose-derived mesenchymal stem cells combined with partially demineralized competitor¿s allograft bone were used to facilitate fusion.During this surgery, a single soft-tissue culture grew low levels of staphylococcus lugdunensis.Antibiotic therapy was initiated for 12 weeks.Unfortunately, 18 months later and 3 and a half years after initial trauma, fusion was still not achieved, and the patient was largely wheelchair bound due to painful weightbearing and persisting ankle instability.A persisting low-grade chronic osteomyelitis due to failed fusion and extensive osteolysis of the talus was presumed.A masquelet treatment plan with full hardware removal, meticulous bone and soft-tissue debridement, application of an unknown external fixator and placement of an unknown appropriate antibiotic spacer with endomedullary extension was performed.Multiple biopsies were obtained, which again showed a low-grade staphylococcus lugdunensis infection.Antibiotic treatment for 14 weeks.Nearly 4 months postoperatively with no sign of infection, a well-healed soft tissue flap, and radiographic evidence of initial bony fusion of the fibula, a final revision was performed.The external fixator and the cement spacer were removed.Cancellous autogenous bone graft was harvested from the ipsilateral femur using the unknown synthes reamer-irrigator-aspirator.The bone graft was placed in the tibiotalar and subtalar joints.An allograft bone block was used to fill the bony defect at the level of the talus.The ankle was definitively stabilized and compressed with a competitor¿s ring fixator.After 6 months, the patient reported markedly decreased pain with weightbearing, and bony fusion of both joints was confirmed radiographically.Fusion was achieved with good hindfoot alignment in slight valgus and no sign of latent infection.The ring-fixator was removed and intensive physical therapy to further improve gait was continued.Although fusion was achieved with marked improvement in mobility and return to activities of daily living, complete weightbearing was not achieved and a slight limp with intermittent use of crutches persisted at 36-month follow-up after fusion.This report is for the unknown synthes 3.5-mm locking compression plate t-plate.This report captures the reported events of failed fusion, persistent ankle instability, low-grade chronic osteomyelitis, extensive osteolysis of the talus and revision surgery, hardware removed.A copy of the literature article is being submitted with this medwatch.This is report 2 of 3 for (b)(4).

• Brand Name: UNK - PLATES: 3.5 MM LCP DISTAL TIBIA T-PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12508573
• MDR Text Key: 272542914
• Report Number: 8030965-2021-07904
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/09/2021

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: 09/09/2021
• Initial Date FDA Received: 09/21/2021
• 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
• Patient Age: 47 YR